- Unknown (San Diego, CA)
- Executive Director, Drug Safety & Pharmacovigilance About the Company Fast-growing biopharmaceutical company Industry Health, Wellness and Fitness Type Public ... the Role The Company is seeking an Executive Director for Drug Safety and Pharmacovigilance . The successful candidate will be at the forefront of ensuring the… more
- Unknown (Bothell, WA)
- Vice President, Pharmacovigilance & Drug Safety About the Company Innovative biotechnology (BioTech) company specializing in antibody-based therapeutics Industry ... biotechnology About the Role The Company is seeking a Vice President, Pharmacovigilance & Drug Safety to be the global safety leader for its innovative… more
- Insmed Incorporated (NJ)
- …metrics to appropriate teams and individuals.Lead all aspects of medical safety and pharmacovigilance activities conducted in partnership with external ... DO with 8+ years of pharmaceutical industry experience within Drug Safety / Pharmacovigilance working with both investigational and marketed products.… more
- Unknown (Dallas, TX)
- …throughout their lifecycle. The ideal candidate will have at least 10 years' experience in pharmacovigilance and drug safety , with a minimum of 5 years in a ... Executive Director of Global Pharmacovigilance About the Company Forward-thinking biotechnology company Industry...the collection, analysis, and reporting of adverse events and safety data, and ensuring the timely submission of … more
- Unknown (Portland, OR)
- … safety professionals and PV scientists, and ensuring compliance with drug safety and pharmacovigilance regulations. The Executive Medical Director will also ... the development of risk management plans, and the training of staff in safety and pharmacovigilance . Applicants must have a Medical Degree (MD) and a minimum of… more
- Merck & Co. (Boston, MA)
- …Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… 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, ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- Insmed Incorporated (NJ)
- …heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance , clinical quality, and biostatistics.Provide medical leadership for key ... company at regulatory meetings including presentation at Advisory Committee Meetings.Prepare safety charters, DMC charters, or other specific management plans and… more
- Merck & Co. (Rahway, NJ)
- …and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations ... Training Programs, FDA Regulations, Life Science, Pharmaceutical Regulatory Affairs, Pharmacovigilance , Policy Implementation, Regulatory Affairs Compliance, Regulatory Affairs Management,… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …Medical Monitoring: Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and interpret safety signals, adverse ... events, and efficacy data in collaboration with pharmacovigilance teams. Target Product Profile (TPP) Contributions: Develop and refine TPPs by outlining desired… more
- Boehringer Ingelheim (Duluth, GA)
- …or related field experience. + Previous pharmaceutical industry or drug safety / pharmacovigilance experience preferred. + Thorough knowledge of animal disease ... Boehringer Ingelheim's high regard for our employees. The Veterinarian, Pharmacovigilance ensures pharmacovigilance compliance with all competent authorities… more
- Lilly (Indianapolis, IN)
- …development portfolio. **This role encompasses four strategic imperatives:** + **Patient Safety & Pharmacovigilance Technology:** Lead the enterprise strategy ... for drug safety technology systems, ensuring world-class pharmacovigilance capabilities to characterize the safety profile of Lilly development and marketed… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …in North America: USA & Canada. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient, ... accurate and timely reporting of adverse events, aggregate safety reports (ie PADER) and other Pharmacovigilance ...aggregate safety reports (ie PADER) and other Pharmacovigilance activities. This person will assist the LPVRP with… more
- GE HealthCare (IL)
- …be responsible for supporting the preparation and maintenance of GE HealthCare Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and ... **Job Description Summary** The Pharmacovigilance Agreement Associate, working on the Global ...variety of internal groups and stakeholders, communicate with the safety organizations of the respective partners, and ensure compliance… more
- BeOne Medicines (Emeryville, CA)
- …medical field or biological science and 8+ years of experience as a Safety ( Pharmacovigilance ) Scientist. + MD (or internationally recognized equivalent) plus ... **General Description:** The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ MD or equivalent with 4+ years of experience in drug safety / pharmacovigilance , with a focus on clinical trials and cross-functional collaboration ... **Qualifications** **:** + 5+ years of experience in drug safety / pharmacovigilance , with a focus on clinical trials and cross-functional collaboration.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …members, review of team output. + Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management ... / corporate level, including safety in clinical development and post-marketing safety . + Understanding of pharmacovigilance regulation in major markets and… more
- Takeda Pharmaceuticals (Boston, MA)
- … pharmacovigilance (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV); Identify and develop methods for statistics ... to support the department's data needs; Solve business problems in drug safety which provide an increased understanding of such tools and techniques. Identify… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Patient Safety Physician - Inflammation has responsibility for the pharmacovigilance risk management activities of investigational compounds on a global level. ... members, review of team output. + Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management… more
- Organon & Co. (Jersey City, NJ)
- …interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance , Chemistry, Manufacturing and Controls ... for the general medicines portfolio of products. + Support Drug Safety and Pharmacovigilance with activities such as review of non-clinical literature for new… more
