Pharmacovigilance & Drug Safety Associate Director

Job Description

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:

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• Provide strategic leadership for drug safety and pharmacovigilance activities across multiple compounds in development.
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• Develop and oversee clinical safety strategy, including signal detection, risk assessment, and proactive risk management.
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• Serve as the primary point of contact for Drug Safety Operations, ensuring effective oversight of internal teams and vendors.
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• Lead selection, governance, and performance management of Drug Safety CROs, including RFIs, RFPs, and data migrations.
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• Develop, implement, and maintain pharmacovigilance SOPs covering signal detection, DSURs, and safety reporting.
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• Review and approve safety content for regulatory and clinical documents such as protocols, IBs, CSRs, and RMPs.
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• Ensure global regulatory compliance and support Health Authority inquiries related to safety and pharmacovigilance.
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• Streamline safety processes across CROs and functions to improve efficiency, data quality, and compliance.
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• Collaborate cross-functionally with Clinical Development, Medical Writing, Data Management, Biostatistics, Legal, and Regulatory Affairs.
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• Provide medical safety expertise through case review, metrics oversight, committee participation, and ongoing safety surveillance.
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If you have experience with the responsibilities mentioned above, please send me your updated resume.