Director, Drug Safety
Tris Pharma · US
Description Director, Drug Safety for Tris Pharma, Inc to work at our Monmouth Junction, NJ loc. May telecommute up to 2 days per week. Responsible for strat...
Job description
Description Director, Drug Safety for Tris Pharma, Inc to work at our Monmouth Junction, NJ loc. May telecommute up to 2 days per week. Responsible for strategic leadership + operational oversight of global pharmacovigilance (PV) + drug safety programs for marketed + investigational products. Ensure regulatory compliance, risk management, clinical trial safety oversight + cost-effective vendor management + maintain highest industry standards. Direct all aspects of PV ops + ensure compliance w/ FDA, EMA, Health Canada + ICH GVP regs. Conduct medical review + analysis of individual case safety reports (ICSRs) + aggregate reports (e.g., PADERs, PSURs, DSURs). Lead signal detection + risk assessment, ensure prompt ID + mitigation of potential safety concerns. Collab w/ clinical development teams to provide safety input on study protocols, investigator brochures, statistical analysis plans + informed consent forms. Oversee safety data collection, reconciliation, + analysis in clinical trials to ensure regulatory compliance. Provide guidance in Risk Management Plans (RMPs) + Risk Eval + Mitigation Strategies (REMS). Serve as primary liaison w/ FDA, EMA + other regulatory agencies + prep...