- Sanofi Group (Morristown, NJ)
- ** Global Pharmacovigilance Audit & Inspection Readiness Coordinator - VIE Contract** + _Location: United States of America, Morristown_ + _Target start ... on the lives of countless people worldwide. As_ **_Global Pharmacovigilance Audit & Inspection Readiness..._in our Quality Compliance team you will work with global teams to integrate quality standards and initiatives. Routine… more
- IQVIA (Durham, NC)
- ** Global Pharmacovigilance Operations Specialist** **Home-Based in North America, East Coast strongly preferred** **Why DSSS?** Data Sciences Staffing Solutions, ... Pharmacovigilance and Risk Management experience in clinical trials supporting global pharmacovigilance activities including but not limited to case… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory requirements worldwide + Supports and advocates the vision and mission of Global Patient Safety & Pharmacovigilance (PSPV) as a member of the ... Medical Review and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory requirements worldwide + Provides a robust, patient-centered,… more
- GE HealthCare (PA)
- **Job Description Summary** The GE HealthCare Global Pharmacovigilance Organization, part of Pharmaceutical Diagnostics, ensures patient safety by maintaining a ... is a unique opportunity to understand the advantages and complexities of a global pharmacovigilance organization. Daily activities may involve, but are not… more
- United Therapeutics (PA)
- …This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper ... and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role...and provide support for recruitment process (as needed) + Inspection and Audit Management: Act as the… 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
- Chiesi (Cary, NC)
- …checks with new documents obtained + Supports the study teams on eTMF audit and inspection readiness activities + Maintaining assigned trackers and information ... Intern, Global Rare Diseases Clinical Trial Administrator - Summer...Department: GRD Clinical Development Job Type: Intern Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Temporary Location: Cary,… more
- Amgen (Thousand Oaks, CA)
- …meetings and tracking through to closure. + Collating and verifying objective evidence for inspection & audit driven CAPAs/EVs. + Data entry into the risk ... assessment tool (using risk assessment methodology) + Support Safety and Global Development teams in GxP inspection readiness and inspection management… more
- Rhythm Pharmaceuticals (Boston, MA)
- Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare ... trials. The individual will lead and/or support GCP audits, maintain inspection readiness, and manage key relationships internally and externally. This impactful… more
- Takeda Pharmaceuticals (Concord, NH)
- …Minimum of 5 years prior experience in pharmaceutical industry in a drug safety/ pharmacovigilance global setting + Experience in with training adult learners and ... support to all functional areas within PSPV in a Pharmacovigilance (PV) regulated environment. + Supports the development and... level + Participate in and support for PV audit / Inspection and ensure its readiness with compliance… more