- Merck & Co. (Rahway, NJ)
- …authoring/publishing platforms.Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing, PV case ... and improve lives around the world.Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital… more
- Formation Bio (New York, NY)
- …including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer ... and CSV activities across various entities, investigator sites, research organizations, clinical and nonclinical studies, PV vendors, and CDMOs. Maintain… 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
- CSL Behring (King Of Prussia, PA)
- …strategies align with current and emerging requirements. - **Safety and Pharmacovigilance Intelligence** Monitor, track and analyze global PV regulations, ... developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager, Regulatory Science? The job is in our King of Prussia, PA… more
- Parexel (Bismarck, ND)
- …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
- Genentech (South San Francisco, CA)
- **The Position** ** Senior Pharmacovigilance ( PV ) Clinical Scientist** **Department Summary** The Senior Pharmacovigilance ( PV ) Clinical ... applicable health authority regulations and internal company standards. The Sr. PV Clinical Scientist ensures ongoing inspection readiness, regulatory adherence,… more
- GE HealthCare (IL)
- **Job Description Summary** The Head of Pharmacovigilance at GE HealthCare will lead and oversee all US & Canada (USCAN) pharmacovigilance activities for the ... business to ensure the safety of the company's products. This is a senior leadership role, and although an individual contributor position, it is mission critical… more
- Bayer (Whippany, NJ)
- …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
- Ascendis Pharma (Palo Alto, CA)
- …of Adverse Events to Ascendis Global Patient Safety. + Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial ... skills. The Director, Head, ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction… 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
- 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
- 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
- Merck (Rahway, NJ)
- …platforms. + Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing, PV case ... improve lives around the world. Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital… more
- J&J Family of Companies (Raritan, NJ)
- …to thrive in a global, matrix environment. + Significant skills in clinical medicine and pharmacovigilance , including experience in post-marketing safety ... to technical and lay groups at public meetings desirable. + Knowledge of Good Clinical Practices and PV regulatory requirements, the conduct of clinical … 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
- Genentech (Boston, MA)
- …Life Sciences space. + You have 10+ years of industry experience ( clinical development/safety/ pharmacovigilance ) with 6+ years of safety-related experience in ... a broad knowledge of the scientific aspects of safety, PV and clinical /patient risk management (eg, via...+ You have previous experience of operating as a senior level global safety leader + You have strong… more
