Discover International ยท 1 week ago
Pharmacovigilance & Drug Safety Associate Director
United States
Contract
Remote
Lead/Staff, Director/ExecutiveDiscover 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.
Professional ServicesRecruitingStaffing Agency
Hiring Manager
Nabil Rhrarba
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
Qualification
Required
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
Discover International
Discover International is consulting solution that offer extensive global and local network, specialist skills and, strategic guidance.
Founded in 2013
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase