- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:We are seeking a highly experienced Senior Director , DSPV Medical Safety to help us expand what's possible for ... patients with serious diseases. Reporting to the Executive Director , DSPV, you'll be the medical expert...metrics to appropriate teams and individuals.Lead all aspects of medical safety and pharmacovigilance activities… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's ... with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance , clinical quality, and biostatistics.Provide medical leadership… more
- Merck & Co. (Rahway, NJ)
- …Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions ... Job Description Associate Director , Regulatory Submissions Archive Operations - Location: Rahway, NJ (Hybrid role - onsite 3 days per week required) - Functional… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and interpret safety signals, adverse events, ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and ...and efficacy data in collaboration with pharmacovigilance teams. Target Product Profile (TPP) Contributions: Develop and… more
- Merck & Co. (North Wales, PA)
- …Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, ... technology and applying rigorous scientific and ethical standards.The Senior Director (Senior Principal Scientist) has primary responsibility for the planning… more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical** is seeking a Medical Director of Pharmacovigilance for a fulltime, Direct Hire role with a pharmaceutical client based in the ... bonus and equity **Position Overview:** The Director , Pharmacovigilance is responsible for leading global drug safety...the continental US The position will report to Senior Director , Medical Monitoring and Pharmacovigilance .… more
- AbbVie (North Chicago, IL)
- …the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, ... pharmacovigilance documents, including but not limited to medical safety assessments, regulatory responses, and risk...risk management strategy for assigned products Key Stakeholders: Group Medical Director , Executive Director , TA… more
- BeOne Medicines (San Mateo, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs ... pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and...on the program / portfolio being led. The Executive Medical Director serves as Product Safety… more
- ThermoFisher Scientific (Wilmington, NC)
- …future.** **Location/Division Specific Information:** Join Thermo Fisher Scientific as a Global Medical Safety Lead Physician(FSP) based in the United States and ... yourself and contribute to breakthrough solutions , the Global Medical Safety Lead could be a great...the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance /drug safety (global experience is a plus)… more
- AbbVie (North Chicago, IL)
- …for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic ... and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: *… more
- BeOne Medicines (Emeryville, CA)
- …regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective ... **General Description:** The Director , Safety Scientist supports assigned compounds...performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely… more
- Taiho Oncology (Princeton, NJ)
- …an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and ... on your experience in our rapidly evolving organization. Position Summary: The Associate Director , PV Sciences role will lead medical surveillance activities for… more
- Taiho Oncology (Princeton, NJ)
- …a dynamic, collaborative, and global cross-functional environment. Position Summary: The Director , Quality Assurance, ( Pharmacovigilance [PV]) reports into the ... PV and is responsible for partnering with the Sr. Director of QA, PV and PV colleagues to assure...Taiho Global GXP operations. + Review and contribute to Safety Data Exchange Agreements (SDEA's), Pharmacovigilance Agreements… more
- Amgen (Washington, DC)
- …lives of patients while transforming your career. **Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote** **What you will ... all use our unique contributions to serve patients. The Medical Safety professional we seek is a...practice (including hospital based) setting **Preferred Qualifications:** + Industry pharmacovigilance (PV) experience + Product safety in… more
- Takeda Pharmaceuticals (Boston, MA)
- …process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) ... the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will... Safety Board and similar forums. The Senior Medical Director will be a key player… more
- Lilly (Indianapolis, IN)
- …Case Management Medical Review Scientist is responsible for conducting comprehensive medical review of Individual Case Safety Reports (ICSRs), ensuring the ... inform Medical Review work. + Present strong understanding of pharmacovigilance and clinical research principles, regulations, and be able to interpret complex… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to join the **Patient Safety Strategic Operations** team as an **Associate Director , Patient Safety Medical Device Safety ** responsible for ... strategies and ensure operational excellence through successful business partner collaboration. The Associate Director , PS Medical Device Safety will be a … more
- ThermoFisher Scientific (Greenville, NC)
- …+ Direct experience in safety / Pharmacovigilance (comparable to 2 years) **For Medical Director Level:** + MD or equivalent required. Active medical ... management and oversight of all contracted services. **Discover Impactful Work:** The Associate/ Medical Director provides medical oversight of clinical… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Regeneron's Patient Safety Organization is looking for a Senior Director (Obesity) to join our organization! **In this role, a typical day might include:** + ... Safety (GPS) Therapeutic Area (TA) Head, the Senior Director GPS Lead, serves as the first point of...management and minimization activities. + Ability to utilize GPS safety database for purposes of medical case… more
