Pharmacovigilance & Drug Safety Associate Director

L7

discover internationalDenver, CO3 days ago
Hi Network! Our client is urgently looking for a Drug Safety & Pharmacovigilance Associate Director to work remotely, for a 6 month-contract, extendable. Please find below the job description: Provide strategic leadership for drug safety and pharmacovigilance activities across multiple compounds in development. Develop and oversee clinical safety strategy, including signal detection, risk assessment, and proactive risk management. Serve as the primary point of contact for Drug Safety Operations, ensuring effective oversight of internal teams and vendors. Lead selection, governance, and performance management of Drug Safety CROs, including RFIs, RFPs, and data migrations. Develop, implement, and maintain pharmacovigilance SOPs covering signal detection, DSURs, and safety reporting. Review and approve safety content for regulatory and clinical documents such as protocols, IBs, CSRs, and RMPs. Ensure global regulatory compliance and support Health Authority inquiries related to safety and pharmacovigilance. Streamline safety processes across CROs and functions to improve efficiency, data quality, and compliance. Collaborate cross-functionally with Clinical Development, Medical Writing, Data Management, Biostatistics, Legal, and Regulatory Affairs. Provide medical safety expertise through case review, metrics oversight, committee participation, and ongoing safety surveillance. If you have experience with the responsibilities mentioned above, please send me your updated resume.
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Level

ManagerL7

Location

Denver, CO

Occupation

Regulatory Affairs Managers

Industry

Pharmaceutical Preparation Manufacturing

Posted

3 days ago

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