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.
NewScientific Director Oncology - Global Patient Safety AbbVie IncScientific Director Oncology - Global Patient SafetyFlorham Park, NJThe amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and clinical safety findings to facilitate benefit-risk decision making and risk mitigation for oncology products in clinical development as well as on the market.
Senior Safety Data Scientist AbbVie IncSenior Safety Data ScientistFlorham Park, NJThis position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Associate Director, Patient Safety Scientist Bristol Myers SquibbAssociate Director, Patient Safety ScientistPrinceton, NJ$150,300–$182,125 / yearResponsible 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 Associate 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 Gene TherapyDirector, Medical Safety Lead - DSPV, Gene TherapyNew JerseyRemoteWork 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. Reporting to the Sr Director, DSPV Gene Therapy Safety Lead, the Director, Medical Safety Lead serves as the DSPV subject matter expert for assigned products, maintaining deep and up-to-date knowledge of the product portfolio and associated safety profiles.
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.
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 Safety Data Sciences AbbVie IncAssociate Director Safety Data SciencesFlorham Park, NJThis position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite) Merck & Co IncSr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)Rahway, NJ$117,000–$184,200 / yearRequired Skills: Clinical Trials Operations, Cross-Functional Collaboration, Detail-Oriented, Engineering Processes, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Operational Excellence, Performance Improvements, Process Hazard Analysis (PHA), Process Optimization, Regulatory Compliance, Regulatory Compliance Consulting, Risk Analysis, Risk Assessments, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving. This role supports Building 880 in maintaining and continuously improving GMP compliance, safety performance, quality system governance, audit and inspection readiness, deviation and CAPA management, training compliance, risk management, and continuous improvement initiatives that support reliable execution of the clinical supply pipeline.
Product Safety Data Coordinator and Coding Associate ESRhealthcare and EXEC STAFF RECRUITERSProduct Safety Data Coordinator and Coding AssociateNew JerseyRemoteThe 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 Marketed and investigational 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.
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.
Associate Director, Pharmacovigilance/ Product Safety InsmedorporatedAssociate Director, Pharmacovigilance/ Product SafetyNew JerseyRemoteAuthor, 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. Investigate and review emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports, published literature, aggregate reports, toxicology reports, non-clinical studies, and other source.
Director, Medical Safety Assessment Physician, Neuroscience Bristol Myers SquibbDirector, Medical Safety Assessment Physician, NeurosciencePrinceton, NJ$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.
Director, Medical Safety Assessment Physician Bristol-Myers Squibb CoDirector, Medical Safety Assessment PhysicianMadison, NJ$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.
Safety And Occupational Health Manager Bristol Myers SquibbSafety And Occupational Health ManagerSummit West, NJ$91,562–$110,952 / yearBased 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. Perform hazard/risk/exposure/ergonomic assessments for current and future process introductions documented in appropriate change management or new material introduction process, working with outside consultation as needed to determine risk mitigation.
Safety and Occupational Health Manager Bristol-Myers Squibb CoSafety and Occupational Health ManagerSummit West, NJ$91,562–$110,952 / yearBased 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. Perform hazard/risk/exposure/ergonomic assessments for current and future process introductions documented in appropriate change management or new material introduction process, working with outside consultation as needed to determine risk mitigation.
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.
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.