- 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
- 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
- AbbVie (North Chicago, IL)
- …metrics. . Leads the preparation and conduct of PV relevant, internal, and external global audit and inspection process, responses and develops associated ... engaging in new initiatives to continually support the advancement of the Audit / Inspection process, PV investigation/CAPA process and Planned Deviation process.… more
- Bayer (Whippany, NJ)
- …one choice. The Director of Medical Device Safety (MDS) leads and develops global Pharmacovigilance (PV) business processes and analyses clinical data sets ... medical device PMS and Vigilance standards within the function Pharmacovigilance (PV), Medical Device Safety (PVMDS) and beyond, as...with respect to medical device vigilance and PMS from audit and inspection findings. + Represent PVMDS… more
- United Therapeutics (Columbus, OH)
- …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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/ Global Pharmacovigilance (PV) service providers responsible for Call ... Business Partners as required to assure compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV… 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 (Washington, DC)
- …role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, ... management, and remediation + Prepare, analyze, and communicate compliance metrics (eg, audit and inspection data) and other significant compliance information.… 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
- Takeda Pharmaceuticals (Boston, MA)
- …across CPMQ the compliance metrics for CPMQ activities eg audit , inspection , QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and… more
- BeiGene (San Mateo, CA)
- …trends, and the need for process improvements. + Collaborate with R&D Quality Audit Management, Inspection Management, GVP, GLP, and Quality Excellence teams ... is responsible for ensuring that BeiGene's research, development, and pharmacovigilance activities comply with all relevant regulatory requirements, internal… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Responsible for autonomously executing activities associated with the RDQ framework of audit and inspection management, inspection readiness, gap ... : Cambridge, MA **About the role:** Member of the global R&D Quality Compliance organization, providing cross functional expertise...escalation. Partners with RDQ to develop plans for R&D audit programs and inspection preparation to minimize… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... - Quality Due Diligence Assessment Auditor (QDDA) is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through… more
- Astellas Pharma (Northbrook, IL)
- …and PV files are well documented in an up-to-date and complete archive ie, ' audit / inspection ready' status. + Provides input for capacity and resource management ... with both local and regional PV regulations and Astellas global and regional policies and procedures. + Responsible for...local affiliate. + Ensure the local affiliate is PV Audit and Inspection -ready: -Act as the Astellas… more