Director, Drug Safety
Tris Pharma, Inc, Franklin Park, NJ, United States
Description
Director, Drug Safety for Tris Pharma, Inc to work at our Monmouth Junction, NJ location. 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 with FDA, EMA, Health Canada + ICH GVP regulations. 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. Collaborate with 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 Evaluation + Mitigation Strategies (REMS). Serve as primary liaison with FDA, EMA + other regulatory agencies + prepare 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 with global safety regulations. Negotiate pharmacovigilance vendor contracts for cost reduction + ensure quality + regulatory compliance. Oversee vendor performance, ensuring adherence to Safety Data Exchange Agreements (SDEAs) + compliance with pharmacovigilance requirements. Coordinate with QA teams to conduct Health Hazard Evaluations (HHEs) for post‑marketing products, assessing potential safety risks. Timely + accurate reporting of post‑market safety signals, collaborate with 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 departments. May undergo background checks including drug testing/screening.
Wage: $227,490 - $273,133 plus comprehensive benefits.
Requirements Must have Doctor of Medicine degree in Medical or Pharmaceutical Sciences and 15 years relevant experience in global pharmacovigilance and drug safety with direct oversight of FDA, EMA, and Health Canada regulatory requirements. Also requires skills (15 years experience) in: MedDRA 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 years experience) in: leading 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.
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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 with FDA, EMA, Health Canada + ICH GVP regulations. 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. Collaborate with 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 Evaluation + Mitigation Strategies (REMS). Serve as primary liaison with FDA, EMA + other regulatory agencies + prepare 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 with global safety regulations. Negotiate pharmacovigilance vendor contracts for cost reduction + ensure quality + regulatory compliance. Oversee vendor performance, ensuring adherence to Safety Data Exchange Agreements (SDEAs) + compliance with pharmacovigilance requirements. Coordinate with QA teams to conduct Health Hazard Evaluations (HHEs) for post‑marketing products, assessing potential safety risks. Timely + accurate reporting of post‑market safety signals, collaborate with 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 departments. May undergo background checks including drug testing/screening.
Wage: $227,490 - $273,133 plus comprehensive benefits.
Requirements Must have Doctor of Medicine degree in Medical or Pharmaceutical Sciences and 15 years relevant experience in global pharmacovigilance and drug safety with direct oversight of FDA, EMA, and Health Canada regulatory requirements. Also requires skills (15 years experience) in: MedDRA 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 years experience) in: leading 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.
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