- Bayer (St. Louis, MO)
- …the effective and timely completion of PV assessment activities. This is a senior clinical scientist position with deep expertise in key topics in ... lifecycle (pre- clinical to Phase 4 and post-marketing, routine and submission PV activities) and compliance with health authority pharmacovigilance ( PV )… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Director OR Senior Associate Director has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational compounds on a ... of team output. + Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management activities to BI… more
- Amgen (Washington, DC)
- …by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance ( PV ) System Master File and maintain a state of inspection ... periodic report production + Knowledge of processes and regulations for pharmacovigilance and risk management + Clinical /medical research experience **What… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments ... Regeneron's Patient Safety Organization is looking for a Senior Director (Obesity) to join our organization! **In...PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study… more
- AbbVie (Jersey City, NJ)
- …in addition to MD / DO, not required + 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical ... lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose… 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). You ... Professionals (HCPs) serving as Global Safety Leaders (GSL) and PV Scientists for a compound that is **both in...Advanced Degree. + 8 years+ of experience gained in Pharmacovigilance , Clinical Research, or Clinical … more
- Lilly (Indianapolis, IN)
- …audits in support of pharmaceutical development, non- clinical and clinical research, product commercialization, pharmacovigilance and consumer information ... area.** **Minimum of five (5) years' experience related** **to Pharmacovigilance ( PV ) or** **pharmaceutical industry.** **Additional Preferences:** **Experienced… more
- CSL Behring (King Of Prussia, PA)
- …Requirements:** + BS/BA, RN, Pharmacist, or similar. + Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance ( PV ) experience. + Global ... **Position Description Summary:** The Senior Case Processing Oversight Manager is responsible for...all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Analyze and interpret safety data from various sources including non- clinical , clinical , post-marketing and scientific literature. + Conduct signal ... that may impact the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and… more
- Parexel (Columbia, SC)
- …the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support * Provide medical input into PV workflows and projects ... Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical… more