Director, Drug Safety

Tris Pharma•Monmouth Junction, NJ

23h•$227,490 - $273,133•Hybrid

About The Position

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 responses to inquiries + ensure compliance. Ensure ongoing audit + inspection readiness, provide strategic oversight for FDA, EMA + Health Canada inspections. Develop + oversee SOPs + Pharmacovigilance Agreements (PVAs) for compliance w/ global safety regs. Negotiate pharmacovigilance vendor contracts for cost reduction + ensure quality + regulatory compliance. Oversee vendor performance, ensuring adherence to Safety Data Exchange Agreements (SDEAs) + compliance w/ pharmacovigilance reqs. Coord w/ QA teams to conduct Health Hazard Evals (HHEs) for post-marketing products, assessing potential safety risks. Timely + accurate reporting of post-market safety signals, collab w/ regulatory agencies as needed. Manage + mentor pharmacovigilance professionals for continuous training + career development. Provide strategic direction to cross-functional teams across Clinical, Regulatory, + Medical Affairs depts. May undergo background checks incl drug testing/screening.

Requirements

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.
MedDRA coding and training (15 yrs exp)
signal detection, risk assessment, and regulatory submission preparation (15 yrs exp)
managing FDA, EMA, and Health Canada inspections and compliance activities (15 yrs exp)
negotiating vendor contracts and optimizing PV budgets (15 yrs exp)
creating and executing SOPs and PV agreements to ensure inspection readiness and regulatory compliance (15 yrs exp)
serving as primary liaison for FDA and regulatory agencies for drug safety matters (15 yrs exp)
leading in clinical trial safety, regulatory inspections and post marketing surveillance (10 yrs exp)
developing and overseeing Risk Management Plans (RMPs) and REMS for marketed products (10 yrs exp)
working on ADHD, pain management, addiction, and CNS disorder products (10 yrs exp)
Argus and ARISg safety databases including data migration (10 yrs exp)

Responsibilities

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 responses to inquiries + ensure compliance.
Ensure ongoing audit + inspection readiness, provide strategic oversight for FDA, EMA + Health Canada inspections.
Develop + oversee SOPs + Pharmacovigilance Agreements (PVAs) for compliance w/ global safety regs.
Negotiate pharmacovigilance vendor contracts for cost reduction + ensure quality + regulatory compliance.
Oversee vendor performance, ensuring adherence to Safety Data Exchange Agreements (SDEAs) + compliance w/ pharmacovigilance reqs.
Coord w/ QA teams to conduct Health Hazard Evals (HHEs) for post-marketing products, assessing potential safety risks.
Timely + accurate reporting of post-market safety signals, collab w/ regulatory agencies as needed.
Manage + mentor pharmacovigilance professionals for continuous training + career development.
Provide strategic direction to cross-functional teams across Clinical, Regulatory, + Medical Affairs depts.