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 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.
Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Director, Clinical Safety ScientistBasking Ridge, NJ$201,840–$302,760 / yearFull timeRisk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
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.
Director, 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.
Pharmacovigilance (PV) Analytics and Reporting Specialist ECLAROPharmacovigilance (PV) Analytics and Reporting SpecialistLawrenceville, NJResponsibilities: Data Analytics and Reporting Build and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making. 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.
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.
Director, Global Drug Safety & Pharmacovigilance Physician Genmab ASDirector, Global Drug Safety & Pharmacovigilance PhysicianPrinceton, NJFor 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. You will work together with other Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders supporting the Team Lead.
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).
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.
Associate Director, Drug Development Excellence Bristol-Myers Squibb CoAssociate Director, Drug Development ExcellencePrinceton, NJ$156,890–$190,117 / yearThis role partners with business leaders and subject matter experts across Drug Development domains to translate strategic goals into practical frameworks, operating models, process improvements, and improved ways of working that drive measurable and sustainable outcomes across the portfolio. Demonstrated curiosity and working knowledge of AI and emerging technologies as applied to Drug Development operations; ability to critically assess opportunities for AI and digital enablement to improve processes and ways of working, and to engage credibly with technical and data science partners on implementation.
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.
NewPharmaceutical Drug Development Part Time Lecturer Position Rutgers The State University of New JerseyPharmaceutical Drug Development Part Time Lecturer PositionPiscataway, NJThe successful candidate(s) will perform services associated with this course: prepare and submit syllabi, teach requisite classes, grade examinations and papers, provide timely student feedback, respond to students' emails, meet during assigned oce hours and adhere to grade submission policies and deadlines. Under 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.
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.
Principal Scientist, Biostatistics, Clinical Safety Statistics Merck & Co IncPrincipal Scientist, Biostatistics, Clinical Safety StatisticsRahway, NJ$190,800–$300,300 / yearIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Required Skills: Biostatistics, Clinical Risk Management, Clinical Study Design, Clinical Trials, Clinical Trials Analysis, Data Management, Data Science, Numerical Analysis, Safety Management, Statistical Analysis, Statistical Software, Strategic Management, Strategic Planning.
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.
Medical Safety Officer - Solid Tumors Oncology Johnson & JohnsonMedical Safety Officer - Solid Tumors OncologyRaritan, NJ$199,000–$342,700 / yearThe Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight. Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Medical Safety Officer, Immunology Johnson & JohnsonMedical Safety Officer, ImmunologyTitusville, NJThe Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight. Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Global Safety Officer, I&I SanofiGlobal Safety Officer, I&IMorristown, NJ$178,500–$297,500 / yearReview, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling. But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
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.
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 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.
Director, Medical Safety Assessment Physician Bristol-Myers Squibb CoDirector, Medical Safety Assessment PhysicianNJ$286,560–$347,244 / 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.
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.
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.
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.
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.
Development Unit Head Patient Safety - Oncology NovartisDevelopment Unit Head Patient Safety - OncologyEast HanoverThis is a unique opportunity to influence global development programs, drive scientific and medical excellence, lead high-performing safety teams, and collaborate with senior leaders across Novartis to bring transformative medicines to patients worldwide! If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information.
Oracle Argus Safety Techno-Functional Consultant eTeam Inc.Oracle Argus Safety Techno-Functional ConsultantParsippany, NJRemoteDesired Skills: In depth knowledge of PL/SQL, Server Configurations, Life Sciences Domain with special focus on Clinical development and Pharmacovigilance/ Regulatory Compliance. Provide ongoing Maintenance and Support activities, participate in Sales and various pursuits focused on our clients' business needs.
Health Safety Specialist III Rutgers The State University of New JerseyHealth Safety Specialist IIILivingston, NJThe Division of Institutional Planning & Operations (IP&O) employs a workforce of approximately 2,700 staff, represented by 15 collective negotiations agreements, and is responsible for institutional strategic initiatives and operations, which encompasses an expansive range of comprehensive service and business operations across the State of New Jersey. Principally responsible for performing the technical services, investigations, and visual inspections and/or for maintaining records for the University to assure that only sanctioned activities are carried out and that those activities are performed: In accordance with Federal, State & local requirements and University policies/procedures; Without adverse health effects on faculty, staff, students, visitors and community; In a manner that will protect the environment; and.
Associate 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.
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).
Sr. Techno-Functional SME Pharmacovigilance, Data & AI PozentSr. Techno-Functional SME Pharmacovigilance, Data & AIRaritan, NJWe are seeking a highly experienced Senior Techno-Functional Subject Matter Expert (SME) with deep expertise in Pharmacovigilance (PV), Drug Safety, and Risk Management, combined with strong knowledge of Data, Analytics, Artificial Intelligence, and modern digital technologies. The ideal candidate will possess a unique blend of domain expertise, business process knowledge, data strategy, and technical leadership to help design and implement next-generation PV solutions for global life sciences organizations.
Sr. Techno-Functional SME — Pharmacovigilance, Data & AI PozentSr. Techno-Functional SME — Pharmacovigilance, Data & AIRaritan, NJWe are seeking a highly experienced Senior Techno-Functional Subject Matter Expert (SME) with deep expertise in Pharmacovigilance (PV), Drug Safety, and Risk Management, combined with strong knowledge of Data, Analytics, Artificial Intelligence, and modern digital technologies. The ideal candidate will possess a unique blend of domain expertise, business process knowledge, data strategy, and technical leadership to help design and implement next-generation PV solutions for global life sciences organizations.
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.
Senior Pharmacovigilance Operations Specialist SystimmuneSenior Pharmacovigilance Operations SpecialistPrinceton, NJFull timeIt specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). The position carries full accountability for end-to-end safety case processing, including regulatory submissions, hands-on work within the safety database, and CAPA management and coordination.
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.
Executive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJp>The Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.
Senior Director, Clinical Research Eikon Therapeutics IncSenior Director, Clinical ResearchJersey City, NJ$270,000–$294,500 / yearIn partnership with your Manager: • Design and conduct early-stage or late-stage clinical development trials as needed, including, but not limited to assessing clinical safety and efficacy data, performing medical monitoring, and be responsible for other study-related clinical activities. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey offices to ensure effective collaboration and high-quality execution of your clinical work.
NewGlobal Pharmacovigilance (PV) Senior Scientist Amgen IncGlobal Pharmacovigilance (PV) Senior ScientistNewark, NJIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
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.
Director, Digitized Adverse Event Processing & Device Vigilance Bristol-Myers Squibb CoDirector, 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.