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.
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.
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.
Vice President, Drug Safety and Pharmacovigilance DSPV Immunovant IncVice President, Drug Safety and Pharmacovigilance DSPVNew York, NY$400,000–$425,000 / yearMedical expert accountable for overall DSPV strategy and all deliverables of the DSPV function, including responsibilities for pharmacovigilance-related documents (e.g., DSUR) as well as safety sections of key documents (e.g., IBs, RSI, ICFs, study protocols, CSRs) and other applicable activities (IND/CTA, requests for information, regulatory responses). Responsible for oversight of the DSPV department, including building and managing a team of DSPV professionals (operations and safety science) to execute the development strategy and support registrational/post-marketing activities in a compliant and collaborative environment, in accordance with long-term strategic goals.
Senior Director, Drug Safety and Pharmacovigilance BridgeBio Pharma IncSenior Director, Drug Safety and PharmacovigilanceNY$222,300–$255,000 / yearConfigure and administer the Veeva Safety platform (Vault Safety Suite: Safety, SafetyDocs, Signal, Workbench), including user administration, workflow routing, coding configurations (MedDRA, WHO Drug), and business rules. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.
Drug Safety Associate III System OneDrug Safety Associate IIIStamford, ConnecticutMinimum 3 years in Drug Safety Operations role; Experience overseeing CRO teams of case processors preferred. Identify adverse events, seriousness, and listedness/labeledness for case assessment; review additional incoming information to determine reportability.
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.
Senior Director AI and Data Science Drug Discovery and R&D Enablement Lexeo Therapeutics IncSenior Director AI and Data Science Drug Discovery and R&D EnablementNY$255,000–$302,000 / yearDirector will set direction and deliver applied AI/ML solutions across internal workflows and externally facing outputs, ranging from R&D insights to partner-ready analyses, while partnering closely with scientific teams and, when needed, external vendors/partners to solve real problems. It requires a leader who can build, validate, and operationalize models using real-world biopharma data, raise the signal-to-noise ratio in small or unstructured datasets, and include synthetic control arm approaches where appropriate.
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.
Business Development Manager - Drug Discovery Eurofins Scientific SEBusiness Development Manager - Drug DiscoveryNY$115,000–$130,000 / yearEurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
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.
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, Pharmacovigilance / Product Safety Insmed IncDirector, Pharmacovigilance / Product SafetyNJRemote$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. Have leadership of the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents such as Safety Signal Assessment Reports for assigned products and development compounds.
NewExecutive Director, Safety Operations BeOne Medicines AGExecutive Director, Safety OperationsNY$285,800–$365,800 / yearSupervisory Responsibilities: As Function head, leads GPS Safety Operations Team: Global ICSR Management, Global ICSR Submission, Trial Safety Operations, China Post Marketing Safety Operations, Safety Systems and Supporting. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
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.
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.
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 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, Global Safety Lead Agios Pharmaceuticals IncAssociate Director, Global Safety LeadNY$185,369–$308,948 / yearo The current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Proactively assesses and evaluates the clinical implications of safety data from all sources in order to understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing settings as appropriate.
Associate Director, Global Safety Lead - Remote Agios PharmaceuticalsAssociate Director, Global Safety Lead - RemoteNew York, NYRemote$185,369–$308,948 / yearo The current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. • Proactively assesses and evaluates the clinical implications of safety data from all sources in order to understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing settings as appropriate.
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.
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, Safety Franchise Area Lead BeOne Medicines AGExecutive Director, Safety Franchise Area LeadNY$285,800–$365,800 / yearThis includes but not limited to safety strategies and plans; Target Early Profile (TEP)/Target Product Profile (TPP), safety Revised 10 JUNE 2026 content of protocols; Investigator's Brochure; Informed Consent Form; Safety Analysis Plan; clinical study reports; CCDS/product labels; Risk Management Plans; Summary of Clinical Safety and ISS; aggregate safety reports; Health Authority Request for Information/Queries; relevant safety communications (e.g., DIL/DHPC/DHCP letter), and scientific publications. Accountable for safety data content and provide strategic insights and medical leadership to Data Monitoring Committees (DMC)/Safety Monitoring Committees Revised 10 JUNE 2026 (SMC), including input on charters and participation in meetings as required across all molecules/programs within the franchise.
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.
Director, Global Patient Safety Sciences - General Medicine Regeneron Pharmaceuticals IncDirector, Global Patient Safety Sciences - General MedicineNYIn this role, a typical day might include: • This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.). • Represent Global Patient Safety for assigned compounds on cross-functional teams, including Regenerons Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT) and other teams with members external to Regeneron (alliance partners, CROs).
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.
NewDevelopment Unit Head Patient Safety - Oncology Novartis AGDevelopment Unit Head Patient Safety - OncologyEast Hanover, NJ$288,400–$535,600 / yearThis 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information.
Senior Client Partner - Commercial, Real-World Evidence, Clinical, Regulatory & Safety Oracle CorpSenior Client Partner - Commercial, Real-World Evidence, Clinical, Regulatory & SafetyNY$133,000–$217,700 / yearWe are seeking a highly experienced sales and business development professional to drive growth across Commercial, Real-World Evidence (RWE), Clinical, Regulatory, and Safety research services within pharmaceutical and biotechnology organizations. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle''s differing products, industries and lines of business.
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.
Senior Manager, Global Patient Safety - General Medicine Regeneron Pharmaceuticals IncSenior Manager, Global Patient Safety - General MedicineTarrytown, NY$150,500–$245,500 / yearWe may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron. The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area.
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.
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.
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.
Public Safety Officer I FT (32 hours) Unarmed Second Shift AMC Grafton Advocate Health and Hospitals CorporationPublic Safety Officer I FT (32 hours) Unarmed Second Shift AMC GraftonPort Washington, WashingtonTypically requires 1 years of experience in a security, related public safety, or customer service area that includes experiences in responding to emergent situations and identifying and resolving issues that pose a potential risk to patients, visitors, teammates and/or property. Performs routine responsibilities during interior and exterior patrols to ensure safety and security, including but not limited to inspections to identify vulnerabilities, hazards, and fire conditions, audits of Interim Life Safety Measures, patient valuables management, and thorough contraband searches.
Associate Director, Pharmacovigilance/ Product Safety Insmed IncAssociate Director, Pharmacovigilance/ Product SafetyNJRemote$179,000–$232,500 / 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. Author, review and provide input and approval for drug-safety related regulatory reports and clinical study documents including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package and labeling.
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).
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.
NewPV Scientist (Senior Director) Nektar TherapeuticsPV Scientist (Senior Director)NY$280,000–$325,000 / yearDirector, PV Scientist to range from $280,000 to $325,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience. This role serves as the safety expert for company products at all stages of development (Phase 1, 2, 3, and post-approval) and actively participates in the oversight of patient safety across all ongoing clinical trials.
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.
Associate Director, Pharmacovigilance Scientist Sionna Therapeutics IncAssociate Director, Pharmacovigilance ScientistNY$170,000–$215,000 / yearSionna's goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR's nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. The AD PV Scientist will lead or contribute to key PV deliverables and activities associated with signal detection and management, benefit-risk evaluations and regulatory and aggregate safety reporting processes, PV SOP development and management, and oversight of the PV vendor and Clinical CRO safety activities.
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.
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.
Sr. Manager/Associate Director, Pharmacovigilance Hansa Biopharma ABSr. Manager/Associate Director, PharmacovigilanceNY$175,000–$215,000 / yearHansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with acute or complex immune disorders. Our broad therapeutic pipeline based on the company's proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.