Director, Drug Safety

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).(A complete list of duties and benefits can be found at trispharma.com/connect/careers). May undergo background checks incl drug testing/screening. Salary $227,490 $273,133/yr plus comprehensive benefits.Must have Doctor of Medicine degree in Medical or Pharmaceutical Sciences and 15 yrs relevant exp in global pharmacovigilance and drug safety with direct oversight of FDA, EMA, and Health Canada regulatory requirements. Also requires skills (15 yrs exp) in: Med DRA coding and training; signal detection, risk assessment, and regulatory submission preparation; managing FDA, EMA, and Health Canada inspections and compliance activities; negotiating vendor contracts and optimizing PV budgets; creating and executing SOPs and PV agreements to ensure inspection readiness and regulatory compliance; serving as primary liaison for FDA and regulatory agencies for drug safety matters; (10 yrs exp) in: leading in clinical trial safety, regulatory inspections and post marketing surveillance; developing and overseeing Risk Management Plans (RMPs) and REMS for marketed products; working on ADHD, pain management, addiction, and CNS disorder products; and Argus and ARISg safety databases including data migration. Apply at https://www.trispharma.com/connect/careers/.

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