- Nuvalent, Inc. (Cambridge, MA)
- …Reporting to the Senior Medical Director , Pharmacovigilance , the Associate Director , Drug Safety and Pharmacovigilance Scientist is responsible ... knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety… more
- Deciphera Pharmaceuticals (Waltham, MA)
- …preferred; board eligible or OUS equivalent) Minimum of 5 years of experience in Pharmacovigilance / Drug Safety with development and marketed products in a ... . This position will report to the Senior Medical Director of Pharmacovigilance and will be located...informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management experience in PV; required10 or more years of experience within Drug Safety / Pharmacovigilance experience, including both investigational and ... oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- BioSpace (Bridgewater, NJ)
- …for Millennials (TM) , and Best Medium Workplaces (TM) lists. Overview The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's ... identifying trends and implementing corrective and preventative actions. Oversee medical safety and pharmacovigilance activities conducted with external partners… more
- Formation Bio (New York, NY)
- …regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update ... AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ...patients faster and more efficiently. About the Position The Director of Medical Writing will be responsible for developing… more
- Sumitomo Pharma (Pierre, SD)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- PSKW LLC dba ConnectiveRx LLC (Whippany, NJ)
- …Sr. Specialist, Pharmacovigilance is focused on meeting ConnectiveRx's obligations for Drug Safety Monitoring and Reporting as required by the pharmaceutical ... manufacturers we support. The Sr. Specialist, Pharmacovigilance works to ensure that ConnectiveRx is operating in...to positively identify and classify various types of reportable drug safety events. + Basic understanding of… more
- Rhythm Pharmaceuticals (Boston, MA)
- …credentials will be considered if PV experience can be demonstrated. + 1-2 years of Drug Safety and Pharmacovigilance experience. + Knowledge of FDA, ICH, EU ... safety vendor. This position will report to the Director of Pharmacovigilance . Responsibilities and Duties +...Regulations and Requirements for Pharmacovigilance required. + Solid understanding of cross-functional … more
- Lilly (Indianapolis, IN)
- …automation, and systems strategy for all functional areas in GPS. The Sr. Director Safety Data Scientist provides strategy, oversight, and expertise for the ... people around the world. The purpose of the Sr. Director - Safety Data Scientist role is...Computer Science field. + 5 years of experience, supporting drug development areas (eg, Safety , Clinical, Project… more
- Lilly (Indianapolis, IN)
- …talent base that demonstrates judgment-based decision making and provides leadership in drug development and pharmacovigilance . **6) Understand and Support of ... pharmacy, or nursing. + 10+ years' experience in pharmaceutical medicine, pharmacovigilance , or drug development. + Demonstrated effective people leadership.… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug ...Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a… more
- BeOne Medicines (Emeryville, CA)
- General Description: _The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and ... of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug ....depending on the program / portfolio being led. The Director , Safety Scientist provides key support as… more
- J&J Family of Companies (Titusville, NJ)
- …States of America **Job Description:** Johnson & Johnson, is recruiting for a ** Director , Medical Safety Officer, Cardiopulmonary** to be located in Raritan, NJ; ... pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in people management. + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... **Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee… more
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... Skills, and Abilities: + Minimum of 8 years of experience in a Pharmacovigilance / Drug Safety environment with experiences in managing adverse event and SAE… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... empower you to shine? Join us as a PV Risk Management Scientist/Associate Director . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in ... The Global Patient Safety (GPS) Lead role ( Director of...leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global… more
- Pfizer (New York, NY)
- …patient safety from first-in-human and throughout a product's lifecycle. The Sr Director , Safety Program Lead is accountable for the global medical safety ... medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development Additional Qualifications +… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. **Global Safety Medical Director ** **What you will do** Let's do this. Let's change ... of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You… more
- ThermoFisher Scientific (Greenville, NC)
- …find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs ... experience working on clinical trials through every stage of drug development. This includes management and oversight of all...years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years) + Experience… more
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