Job Description
Note: The job is a remote job and is open to candidates in USA. Discover International is seeking a Drug Safety & Pharmacovigilance Associate Director to provide strategic leadership for drug safety activities. The role involves overseeing clinical safety strategy, ensuring compliance, and collaborating with various internal teams and vendors. Responsibilities • 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 Skills • 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 Company Overview • Discover International is consulting solution that offer extensive global and local network, specialist skills and, strategic guidance. It was founded in 2013, and is headquartered in Colchester, Essex, GBR, with a workforce of 51-200 employees. Its website is Apply tot his job