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Pharmacovigilance Quality And Compliance Coordinator
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- The ideal candidate for this position should possess several years of experience in the pharmaceutical industry and pharmacovigilance, along with a demonstrated track record of success in managing quality assurance systems and audits.
- Perform critical oversight of safety vendors to ensure efficient, consistent, and compliant pharmacovigilance activities, requiring minimal supervision.
- Collaborate externally with Drug Safety vendors and business partners on case management issues, processes, and timelines to meet global regulatory requirements for adverse event reporting and data exchange obligations.
- Provide guidance and support in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment and best practices.
- Provide training and guidance to pharmacovigilance staff and stakeholders on compliance-related topics, including adverse event reporting, signal detection, and regulatory requirements.
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