- Amneal Pharmaceuticals (Bridgewater, NJ)
- …Functions: + Responsible for overall leadership of sustaining a leading‐edge, high quality global Pharmacovigilance team operating within the complex global ... regulatory- pharmacovigilance environment while providing strategic leadership for the Global Patient Safety team in all aspects of pharmacovigilance … more
- Bristol Myers Squibb (Summit, NJ)
- …including for- cause and directed activities. + Provide input in the global audit plans based on identified signals/trends/risks/gaps . + Partner ... of the Quality Narrative, specifically developing and contribution the audit / inspection portion . + Apply a risk-based...responsible for the following:** + Defines and oversees the global quality strategy for early R&D Development up to… more
- Nestle (Bridgewater, NJ)
- …establishing and maintaining (GxP) Quality Management Systems for clinical safety and pharmacovigilance processes + Audit and inspection support experience ... and processes with the vendor(s) + Monitor regulatory compliance and coordinate inspection readiness of outsourced pharmacovigilance (PV) activities + Implement… more
- Merck (Rahway, NJ)
- …Trials in scope for GCTO country operations. Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is ... essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures...country / cluster to deliver clinical trials as per global clinical research pipeline requirement. + Strategic country /… more