Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$280,350–$467,250 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
NewDirector, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Drug Safety Physician SystimmuneDrug Safety PhysicianPrinceton, NJFull timeThis individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
Associate Director, Global Drug Safety & Pharmacovigilance Scientist GenmabAssociate Director, Global Drug Safety & Pharmacovigilance ScientistPrinceton, New JerseyFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. · Contribute to safety-related documents for Genmab products throughout product lifecycle from FIH to post-marketing, including robust safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g.
Drug Safety Physician Systimmune IncDrug Safety PhysicianPrinceton, NJ$150,000–$250,000 / yearThis individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
Associate Director, Global Drug Safety and Pharmacovigilance Scientist Genmab ASAssociate Director, Global Drug Safety and Pharmacovigilance ScientistPrinceton, NJ$223,142–$243,960 / yearMust possess at least 7 years (84 months) of progressive post-baccalaureate experience with all of the following: (a) first human trials; (b) overseeing multiple trials with safety inputs at the global level; (c) collaborating with cross-functional teams to continuously improve the efficiency of quality control processes, contributing to audit readiness and ensuring alignment with both client expectations and regulatory requirements; (d) performing ongoing surveillance (including signal detection and evaluation) of safety data; (e) ensuring compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections; (f) international experience with internal and external stakeholders; and (g) Argus Safety Database. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies.
Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs) SanofiGlobal Project Head, Solid Tumor Antibody Drug Conjugates (ADCs)Morristown, NJ$232,500–$335,833.33 / yearThe GPH will collaborate with the Principal Clinical Lead (PCL) and Global Project Manager (GPM) to lead the cross-functional GPT (which includes translational, regulatory, drug manufacturing, safety, medical and commercial compound leads), to ensure correct planning and implementation of end-to-end compound strategy. Key Responsibilities: The Global Project Head (GPH) drives worldwide clinical development and life cycle management for a late-stage Sanofi Antibody Drug Conjugate (ADC) compound within Solid Tumor Oncology.
Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote) Merck & Co IncDirector, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)Rahway, NJRemote$190,800–$300,300 / yearReporting to the Director of Device Regulatory Affairs for Autoinjector Development Programs, the Director/Principal Scientist in Devices and Drug-Device Combinations CMC is responsible to support Device CMC regulatory activities for Our Company's autoinjector, inhalation, and other delivery system products in accordance with global regulations and guidelines and is responsible for technical content input and coordination of CMC submissions for all assigned activities. Primary responsibilities include, but are not limited to: Responsibilities: Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
Associate Director, Early Stage Drug Product Development Acadia Pharmaceuticals IncAssociate Director, Early Stage Drug Product DevelopmentPrinceton, NJ$154,000–$192,700 / yearThe incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
Cancer Pharmacology and Drug Discovery- Tenure Track Faculty (Assistant/Associate) Rutgers The State University of New JerseyCancer Pharmacology and Drug Discovery- Tenure Track Faculty (Assistant/Associate)New Brunswick, NJTo accelerate scientific discovery focused on understanding cancer, innovating cancer treatment, and improving cancer prevention; to provide outstanding, novel, and compassionate patient care; to provide evidence-based and culturally informed education to physicians, nurses, researchers, staff, and the community; and to achieve cancer health equity in our state through outreach to and engagement of our extraordinarily diverse communities. Rutgers Cancer Institute offers world-class quality cancer care providing the most advanced medicines and treatment options for patients in its New Brunswick facility as well as at its network of hospitals across the state through the partnership with the Robert Wood Johnson Barnabas Health System and University Hospital in Newark.
Postdoc - Drug Discovery Development and Application Scientist Rutgers The State University of New JerseyPostdoc - Drug Discovery Development and Application ScientistNew Brunswick, NJUnder Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. The Laboratory for Biomolecular Simulation Research (http://lbsr.rutgers.edu) and Institute for Quantitative Biomedicine (https://iqb.rutgers.edu/) at Rutgers, the State University of New Jersey, is in search of a postdoctoral-level drug discovery application scientist.
Strategy Insights & Planning Consultant - R&D Drug Development Veeva ZS Associates IncStrategy Insights & Planning Consultant - R&D Drug Development VeevaNJLeverage knowledge of R&D Products and Platforms (ex: Veeva, Medidata, IQVIA, etc.) to advise on strategic planning, functional data flow, product implementations (ex: configuration, deployment, migration, and GxP testing), R&D stakeholders & processes, and platform ecosystem management; Advise on R&D business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. In lieu of an MBA or PhD, 5-8 years of relevant work experience may substitute; Required: At least 2 years of direct product services/design/implementation/management experience with Veeva Vault Clinical or Veeva Vault Regulator product suites and data.
Certified Alcohol & Drug Counselor - Per Diem |Behavioral Health Services - Evergreen |24365 Bergen New Bridge Medical CenterCertified Alcohol & Drug Counselor - Per Diem |Behavioral Health Services - Evergreen |24365Paramus, New JerseyCompletion of 270 hours of alcohol and drug education, approved by member boards of the International Certification Reciprocity Consortium (IC&RC) [APCBNJ in New Jersey or its successor], or a regionally accredited college or university which shall be related to the knowledge and skill associated with the functions of an alcohol and drug counselor. Performs all duties with respect, dignity, and impunity according to the ethics of the hospital, adductions field and training, NJ state laws and acts as an advocate for the patients within NBMC, with other facilities establishing positive working relationships within the hospital and the broader community.
Sr Director Product Safety Head - Cellular Therapy, Hematology Johnson & JohnsonSr Director Product Safety Head - Cellular Therapy, HematologyPAPartner closely and effectively with the TASH, the Head of Global Safety Strategy and Risk Minimization (GSSRM), the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) JJ IM, the Qualified Person for Pharmacovigilance (QPPV) JJ IM, other JJ IM R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for products throughout the lifecycle. The Product Safety Head will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of products within the assigned product, preparation of aggregate safety reports and responses to Health Authorities (HA) and, when appropriate, communication of potential and known risks to Senior Management, HAs, Prescribers and/or Patients.
Director, Patient Safety Scientist Bristol-Myers Squibb CoDirector, Patient Safety ScientistPrinceton, NJ$217,520–$263,577 / yearCreates strategy for creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS). The Director, Patient Safety Scientist, is a key partner and strategic advisor to Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence to influence decision-making for assets in development and marketed products by evaluating and mitigating risks.
Director, Medical Safety Lead - DSPV, Gene Therapy Insmed IncDirector, Medical Safety Lead - DSPV, Gene TherapyNJRemote$247,000–$337,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. Work with the DSPV leadership to develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products.
Senior Director, Medical Information & Patient Safety Syneos - Commercial - ProdSenior Director, Medical Information & Patient SafetyNewtown, PACommunication: Exceptional cross-functional leadership and client-facing presentation skills; ability to articulate the value of a tech-enabled clinical contact center to diverse stakeholders. AI & Innovation: Implement and optimize AI-augmented workflows (e.g., intelligent triage, automated AE capture, generative drafting, and sentiment analysis) to drive efficiency, accuracy, and market competitiveness.
Product Safety Data Coordinator and Coding Associate Integrated Resources, IncProduct Safety Data Coordinator and Coding AssociateNutley, NJRemoteThe individual will be responsible for verifying the accuracy and completeness of information for each adverse event report for which he/she is assigned in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with SOPs. Description of Responsibilities:Code and enter information into the Product Safety database for Adverse Events reported in association with client’s Marketed and investigational products.
Product Safety Data Coordinator and Coding Associate Artech LLCProduct Safety Data Coordinator and Coding AssociateNutley, NJRemote$23–$26 / hourThe individual will be responsible for verifying the accuracy and completeness of information for each adverse event report for which he/she is assigned in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with SOPs. Code and enter information into the Product Safety database for Adverse Events reported in association with *** s Marketed and investigational products.
Product Safety Data Coordinator and Coding Associate LancesoftProduct Safety Data Coordinator and Coding AssociateNutley, NJRemote$25Computer proficiency required, including data entry of adverse event information. Description of Responsibilities: Code and enter information into the Product Safety database for Adverse Events.
Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience Bristol-Myers Squibb CoExecutive Director, Medical Safety Assessment Therapeutic Lead, NeurosciencePrinceton, NJ$334,860–$405,769 / yearOversee, Review, and Approve aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.
Director, Medical Safety Assessment Physician Bristol-Myers Squibb CoDirector, Medical Safety Assessment PhysicianPrinceton, NJ$255,860–$310,040 / yearOversee, Prepare, and/or Review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Associate Director, Safety Analysis Scientist Johnson & JohnsonAssociate Director, Safety Analysis ScientistNJ$137,000–$235,750 / yearFunction with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Product Safety Coordinator LancesoftProduct Safety CoordinatorNutley, NJRemote$28.57Preliminary evaluation of clinical trial, spontaneous (post-marketing), and solicited reports of adverse events, including communication with partners and affiliates when necessary to verify completeness and accuracy. Receipt and triage of adverse event reports for marketed and investigational products from all sources.
Product Safety Data Coordinator and Coding Associate Lenmar Consulting, Inc.Product Safety Data Coordinator and Coding AssociateNutley, NJRemoteThe individual will verify the accuracy and completeness of information for each adverse event report for which he/she is assigned in conjunction with the source documents and ensure that all activities are performed in a manner consistent with SOPs. Code and enter information into the Product Safety database for Adverse Events reported in association with ***’s Marketed and investigational products.
Associate Director, Consumer Safety Science Haleon PlcAssociate Director, Consumer Safety ScienceNJ$156,313–$214,930 / yearDefine safety strategy and provide expert safety input to R&D innovation projects for all CH product types (e.g., medicines, medical devices, cosmetics, dietary supplements, digital health projects) within assigned therapeutic category and/or business unit and represent safety function on project teams and other relevant cross-functional forums. In line with a risk-proportionate framework for product vigilance, the Associate Director, Consumer Safety Science is accountable for defining and developing the safety strategy for R&D innovation projects, as well as maintenance of business activities for medium to high-risk products.
NewSr. Global Program Safety Team Lead - Oncology NovartisSr. Global Program Safety Team Lead - OncologyEast HanoverProvide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management. Manage an efficient and successful disease area within the Therapeutic Area (TA)/Development Unit (DU) Medical Safety organization, which provides robust medical and science-driven contribution to BenefitRisk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide.
Associate Director, Program Safety Lead - Job ID: 1908 Ascendis PharmaAssociate Director, Program Safety Lead - Job ID: 1908Princeton, NJ$220,000–$235,000As a key member of the Global Patient Safety Organization and cross-functional product teams, you will shape the strategy, set priorities and lead pharmacovigilance activities for assigned products. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.
Global Safety Officer SanofiGlobal Safety OfficerMorristown, NJ$178,500–$297,500 / yearBut progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
NewAssociate Director, Consumer Safety Science GSKAssociate Director, Consumer Safety ScienceWarren, New JerseyDefine safety strategy and provide expert safety input to R&D innovation projects for all CH product types (e.g., medicines, medical devices, cosmetics, dietary supplements, digital health projects) within assigned therapeutic category and/or business unit and represent safety function on project teams and other relevant cross-functional forums. In line with a risk-proportionate framework for product vigilance, the Associate Director, Consumer Safety Science is accountable for defining and developing the safety strategy for R&D innovation projects, as well as maintenance of business activities for medium to high-risk products.
Distinguished Scientist, Safety Assessment Project Expert SanofiDistinguished Scientist, Safety Assessment Project ExpertMorristown, NJ$178,500–$257,833.33 / yearThese activities entail formulating the nonclinical safety strategies, designing safety pharmacology and toxicology studies, authoring regulatory documents, being a member of an integrated Project Team, interacting with internal and external partners, and interacting with and responding to global regulatory agencies. Our Team: The candidate will be part of a dynamic interactive Preclinical Safety group that spans all aspects of the drug development value chain providing toxicology and safety pharmacology expertise as a member of global project teams.
Senior Patient Safety Case Management Manager Novo Nordisk ASSenior Patient Safety Case Management ManagerPlainsboro, NJAbility to perform all responsibilities of more junior case processing staff; perform any or all of these activities when needed to support the team, including but not limited to processing of serious and non-serious adverse events and associated technical complaints and analysis results related to marketed NNI products into the local intake tool, complaint and global safety databases. To support workflow management and coordination of all daily operations of Product patient Safetys case processing activities, which include the receipt, documentation, triage, case review, and quality assessment of all inbound safety information, including serious and non-serious adverse events, for NNI US marketed products (drugs and devices).
Associate Director, Safety Analysis Scientist 6084-Janssen Research & Development Legal EntityAssociate Director, Safety Analysis ScientistTitusville, New JerseyThe AD SAS will function with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Vice President, Quality & Safety RWJ Barnabas Health Medical IncVice President, Quality & SafetyNew Brunswick, NJ$175,000–$275,000 / yearRequired Background Experience & Competencies Broad-based knowledge of the full scope of quality and regulatory strategy as it applies to an accredited academic medical center or primary teaching hospital of comparable size and scope High-level, complex problem-solving abilities both in groups and in one-on-one situations Ability to translate the mission and vision to everyday work Ability to manage and lead in a matrixed organization Ability to cultivate and foster relationships at every level of the organization (locally at the hospital, within the system, and board relations) Demonstrated success in leading system process improvement initiatives in an academic quaternary care facility Decisive leader, with the ability to understand patient and clinician stakeholder viewpoints and needs and work strategically in the best interest of patients and the organization A strong reputation for sustained, inclusive, trust-based relationships with employees, clinicians, patients, and the community Experience in a system with excellent employee, physician, and patient satisfaction, quality, and clinical outcomes An understanding of information systems as they pertain to clinical excellence, decision support, efficiency, and effectiveness Strong leader of people with the ability to create an environment that supports team morale, improved service, and the highest quality Exhibit strong communication, presentation, and listening skills to ensure facility-wide collaboration and coordination. Patient Safety Assume the role of the Patient Safety Officer overseeing patient safety programs, managing risk, and responding to adverse events Serve as the hospital leader for campus-related occurrence reporting and safety events High Reliability Organization (HRO) Executive Delegate in partnership with system leadership Regulatory Policy and Procedure Executive Sponsor - Oversee the creation and implementation of policy and procedures across the organization This includes staying up-to-date on regulatory requirements and ensuring that the hospital is in compliance with all applicable regulations Facilitate Organizational survey preparedness Administrative Lead for organizational licensure, Certificate of Need, Regulatory Executive Reviewer (all agencies).
Corporate Medical & Chief Safety Officer (USA Remote) Getinge ABCorporate Medical & Chief Safety Officer (USA Remote)Wayne, NJRemoteThe CMO plays a critical role in building a strong, flexible, and capable direct as well as virtual organization, supporting new product and especially fielded product safety across the enterprise, leading Medical Education and any other shared medical services that might be added in the future, serving as the medical and safety director for Surgical Workflows, and serving as a key voice of the clinician and patient within the company. The Corporate Medical and Chief Safety Officer (CMCSO) leads the Corporate Medical function at Getinge, responsible for developing and leading the company-wide Safety function and processes, serving as the Medical & Safety Director for Surgical Workflows, and leading the Medical Education group.
Senior Patient Safety Vendor Management Manager Novo Nordisk ASSenior Patient Safety Vendor Management ManagerPlainsboro, NJ$120,000–$171,000 / yearThis position works closely with including but not limited to the following: all units in Patient Safety, USO QA, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services Bangalore (GBS-BLR), PV & GDP Auditor(s) as well as with counterparts in Global Patient Safety and Contract Owners in NNAS. Collaborates with all units within Patient Safety, other business areas at NNI, GBS-BLR and Global Patient Safety to ensure late reports from suppliers and business partners have been correctly identified and documented as per relevant SOPs and reported to management.
Manager, DSPV Pharmacovigilance Agreements Insmed IncManager, DSPV Pharmacovigilance AgreementsNJRemote$133,000–$173,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. Reporting to the Senior Director, DSPV Operational Excellence and Compliance, you'll be responsible for the end-to-end development, implementation, and lifecycle management of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Pharmacovigilance Clauses (PVCs).
Associate, Global Pharmacovigilance Pharming Group NVAssociate, Global PharmacovigilanceNJ$70,000–$95,000 / yearDetermine and perform appropriate case follow-up activities including generation of follow-up requests via fax, phone, mail, or e-mail and product complaint notifications to consumers, HCPs, Specialty Pharmacies and/or vendors. Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.
Scientist, Pharmacovigilance Amneal Pharmaceuticals IncScientist, PharmacovigilancePiscataway, NJ$90,000–$110,000 / yearMedical Affairs: A designated representative from the Medical Safety Science Department with technical expertise to verify the medical and scientific integrity of the Asset or Communication and to ensure that medical and/or scientific information contained in the Asset or Communication is accurate and not misleading, medically relevant, supported by the references provided, well-substantiated by scientific data, truthful and balanced, and scientifically rigorous. Additional Responsibilities: Medical Affairs: Team lead for medical affairs sub-groups for MIRF (Medical Information Request Forms): Information request from HCP''s which are submitted by IMPAX sales reps and MSLs and these requests are managed by medical affairs using SRL''s and escalated to MSL''s if required.
Director, Pharmacovigilance Scientist Bristol Myers SquibbDirector, Pharmacovigilance ScientistPrinceton, NJ$217,520–$263,577 / yearRisk Management Planning & Execution: Creates strategy for creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS). The Director, Patient Safety Scientist, is a key partner and strategic advisor to Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence to influence decision-making for assets in development and marketed products by evaluating and mitigating risks.
Clinical Research Director - Rare Diseases SanofiClinical Research Director - Rare DiseasesMorristown, NJ$178,500–$257,833.33 / yearExperience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization. On Clinical Development, the CRD: Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes.
Business Intelligence Analyst - Pharmacovigilance Specialist GTT, LLCBusiness Intelligence Analyst - Pharmacovigilance SpecialistLawrenceville, NJThe PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall PS needs. The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across PS.
Medical Director, Pulmonary SanofiMedical Director, PulmonaryMorristown, NJ$178,500–$257,833.33 / yearMain responsibilities: Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned the respective therapeutic area products. Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of the respective therapeutic area products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities.
Medical Director, Dermatology SanofiMedical Director, DermatologyMorristown, NJ$178,500–$257,833.33 / yearMain responsibilities: Develop strategy and tactics for an integrated Medical Plan (Medical Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned Dermatology products. The Medical Director, Dermatology functions internally as the product expert to lead the development and execution of the most efficient and integrated US medical/scientific strategy for Dermatology products, including scientific evidence generation and scientific information exchange with all key stakeholders.
Sr. Medical Director, Pulmonary SanofiSr. Medical Director, PulmonaryMorristown, NJ$206,250–$297,916.66 / yearProvide leadership to the Dermatology/Rheumatology, US Medical Immunology team (Medical Directors, Medical Science Liaison Managers, MSLs & Medical Operations Manager) by cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities, while attracting, developing and retaining top talent. • In collaboration with Global and Alliance Medical partners, be accountable and lead the development of an Integrated Medical Plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research (phase IIIB-IV and ISTs)) and annual budget for the respective Therapeutic Area.
NewDirector, Digitized Adverse Event Processing & Device Vigilance Bristol-Myers Squibb CompanyDirector, Digitized Adverse Event Processing & Device VigilancePrinceton, NJ$217,520–$263,577 / yearLead implementation of AI, NLP, OCR, RPA, and Large Language Model (LLM)-assisted tools to enable automated ingestion, triage, and processing of adverse event data from structured and unstructured sources (e.g., EHRs, free-text narratives, digital health applications, social media, medical literature, and partner data transfers). The Director, Digitized Case Processing & Device Vigilance is a senior leadership role accountable for the end-to-end strategy, design, implementation, and continuous improvement of digitized adverse event (AE) case processing workflows within BMS's global PV Operations & Systems function.
Clinical Dietitian I RWJ Barnabas Health Medical IncClinical Dietitian ILinden, NJ$73,427–$94,938 / yearPatient Safety Competencies: Monitors closely for high-risk food and drug interactions; ensures patients at nutritional risk receive timely assessments and adheres strictly to medical error/risk reporting protocols. Patient & Staff Education: Conducts structured in-service education programs for the renal staff regarding dialysis nutritional guidelines; coordinates and participates in initial education sessions and follow-ups for THRIVE patients.
Manager, DSPV Operations Insmed IncManager, DSPV OperationsBridgewater, NJ$133,000–$173,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. About the Role: Supports the oversight of the Drug Safety and Pharmacovigilance Operations and Vendor Management activities as well as DSPV business partner relationships ensuring compliance with ICH-GCP and GVP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures.