- System One (Plainsboro, NJ)
- Title: Global Drug Safety and PV Compliance Associate Location: Must be local for hybrid schedule in Princeton area Rate: Up to $42/hour (dependent on ... Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS& PV ) Department. The...within the Global Drug Safety and Pharmacovigilance (GDS& PV ) Department. The ideal candidate will possess a methodical… more
- Ascendis Pharma (Princeton, NJ)
- …direction of Head of GPS Medical Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio. ... and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs. . Monitors industry best practices,… more
- Taiho Oncology (Princeton, NJ)
- …You will contribute to the growth and exciting change happening at Taiho PV and have greater opportunity to expose/contribute to the company's multiple portfolio, ... compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance. + Responsible for Individual Case Safety Report (ICSR) review.… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... preparedness and readiness of Patient Safety and Pharmacovigilance (PSPV) and country PV offices in anticipation of regulatory inspections and audits. + Active… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... This role works directly all GPV stakeholders, including GSOs, PV Scientists, to accurately interpret and translate business needs...is important that the Business Analyst has a strong PV knowledge and working relationships with the user community… more
- Merck (Rahway, NJ)
- …according to timelines outlined in applicable regulations + Case entry for non- PV -Works countries for assigned products + Aggregate report preparation and submission ... Authorities according to timelines outlined in applicable regulations + Support national PV teams as applicable + Product expert for assigned products + Provide… more
- Sumitomo Pharma (Trenton, NJ)
- …experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work collaboratively with ... is essential. **Job Duties and Responsibilities** + Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... get started? **Main Responsibilities:** **Internal & External Safety Expert:** + Provide PV and risk management expertise to internal and external customers + Safety… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …inspection readiness across all clinical trial sites, clinical and Pharmacovigilance ( PV ) operations. + **Audit Management:** Oversee the planning, execution, and ... Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings. + **Data Integrity:** Ensure the… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US (FDA regulatory agencies),participate in audits ... and provide support in external audits. Responsible for driving successful PV audits to achieve no critical findings and provide post inspection report with… more