Associate Director, Pharmacovigilance Operations at Third Rock Ventures in Cambridge, MA

The Associate Director, PV Operations will be responsible for building and maintaining PV operational functions including case management oversight, drug safety systems, safety data analysis, and reporting in compliance with global regulations. This individual will oversee all aspects of adverse event collection, processing and reporting from clinical trials as well as the flow of safety information. The successful candidate is experienced in the operationalization of safety reporting and the characterization of safety risks. In this role, you will work closely with program teams and the clinical development function to provide guidance in adverse event collection and safety management throughout the lifecycle of Relay’s precision oncology drug candidates.

The Role:

• Prepares and maintains departmental policies that address the processing, analysis, and reporting of safety information to ensure proactive surveillance of products in development
• Develops departmental procedural documents including regulatory reporting calendars and requirements matrices per global requirements
• Manages the global pharmacovigilance process to ensure compliance with all applicable laws and regulations
• Develops and maintains study-specific safety management plans in conjunction with study teams
• Provides appropriate oversight of the CRO performing case management and study support activities including safety database related activities
• Conducts QC of SAE / ICSR cases in safety database to ensure quality and timeliness of case processing
• Supports the medical function in the analysis, identification and reporting of possible data trends
• Participates in preparation and review of safety sections of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports and regulatory submissions
• Oversees of activities associated with safety committees, internal safety review, and external independent committees
• Ensures awareness and training of appropriate company personnel and external groups of PV drug safety principles, policies and SOP

Your Background:

• Healthcare degree. RN or PharmD preferred.
• 4-6 years drug safety experience in biopharmaceutical setting. Experience in oncology and global programs is preferred
• Expert knowledge of global PV requirements, e.g. US Code of Federal (CFR) regulations, European Union (EU), Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
• Strong knowledge of drug safety databases
• Experience in managing safety operations outsourced to contract research organizations
• Effective communication skills