- Insight Global (Livingston, NJ)
- …of experience within the pharmaceutical or healthcare industries *3-5 years of pharmacovigilance /drug safety related experience *Must have knowledge of current ... guidance, and the regulations and guidance of other regulatory agencies regarding pharmacovigilance and medication safety *Ability to work with a… more
- Ascendis Pharma (Princeton, NJ)
- …issues are identified. . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all ... Pharmacovigilance Department direction, standards, and processes for supporting safety monitoring activities. . Collaborates closely with the Medical Assessment… more
- Sanofi Group (Morristown, NJ)
- …Your skills could be critical in helping our teams accelerate progress. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety ... group of process, method and technology experts dedicated to supporting Global Safety Officer (GSO) and Pharmacovigilance Scientists (PVS) monitoring of product… more
- Sanofi Group (Morristown, NJ)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups.… more
- Astrix Technology (Monmouth County, NJ)
- …and on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports ... or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with safety databases, literature… more
- System One (Plainsboro, NJ)
- …detail-driven Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess ... Title: Global Drug Safety and PV Compliance Associate Location: Must be...governance, inspection readiness, and cross-functional collaboration across our global safety network. Key Responsibilities Inspection & Audit Readiness -… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in ... **Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's… more
- Colgate-Palmolive (Piscataway, NJ)
- …Summary** Serve as the Lead point of contact for all Global Pharmacovigilance functions and processes for internal & external customers and stakeholders. Contribute ... key support functions in delivering vision, training and awareness of Global Pharmacovigilance to PV and all Colgate-Palmolive employees + Lead the operational… more
- Merck (Rahway, NJ)
- …Communication, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Management Process, Pharmaceutical Regulatory Compliance, ... **Job Description** **The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:** + Case review/approval… more
- United Therapeutics (Trenton, NJ)
- …and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety ... ensuring compliance, and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting… more