Director, Drug Safety
BioSpace, Franklin Park, NJ, United States
Overview
Director, Drug Safety for Tris Pharma, Inc
to work at our Monmouth Junction, NJ location. May telecommute up to 2 days per week.
Responsibilities
Provide strategic leadership and operational oversight of global pharmacovigilance (PV) and drug safety programs for marketed and investigational products.
Ensure regulatory compliance, risk management, clinical trial safety oversight, cost-effective vendor management, and adherence to highest industry standards.
Direct all aspects of PV operations and ensure compliance with FDA, EMA, Health Canada, and ICH GVP regulations.
Conduct medical review and analysis of individual case safety reports (ICSRs) and aggregate reports (e.g., PADERs, PSURs, DSURs).
Lead signal detection, risk assessment, and ensure prompt identification and mitigation of potential safety concerns.
Collaborate with clinical development teams to provide safety input on study protocols, investigator brochures, statistical analysis plans, and informed consent forms.
Oversee safety data collection, reconciliation, and analysis in clinical trials to ensure regulatory compliance.
Provide guidance in Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS).
Serve as primary liaison with FDA, EMA, and other regulatory agencies; prepare responses to inquiries and ensure ongoing compliance.
Ensure audit and inspection readiness; provide strategic oversight for FDA, EMA, and Health Canada inspections.
Develop and oversee SOPs and Pharmacovigilance Agreements (PVAs) for compliance with global safety regulations.
Negotiate pharmacovigilance vendor contracts to reduce costs while ensuring quality and regulatory compliance.
Oversee vendor performance and ensure adherence to Safety Data Exchange Agreements (SDEAs) and pharmacovigilance requirements.
Coordinate with QA teams to conduct Health Hazard Evaluations (HHEs) for post-marketing products and assess potential safety risks.
Ensure timely and accurate reporting of post-marketing safety signals; collaborate with regulatory agencies as needed.
Manage and mentor pharmacovigilance professionals for continuous training and career development.
Provide strategic direction to cross-functional teams across Clinical, Regulatory, and Medical Affairs departments.
May undergo background checks including drug testing/screening.
Requirements
Must have Doctor of Medicine degree in Medical or Pharmaceutical Sciences.
15 years of relevant experience in global pharmacovigilance and drug safety with direct oversight of FDA, EMA, and Health Canada regulatory requirements.
Skills (15 years of experience): 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 on drug safety matters.
Additional experience (10 years): leading in clinical trial safety, regulatory inspections, and post-marketing surveillance; developing and overseeing Risk Management Plans (RMPs) and REMS for marketed products; experience with ADHD, pain management, addiction, and CNS disorder products; working with Argus and ARISg safety databases including data migration.
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to work at our Monmouth Junction, NJ location. May telecommute up to 2 days per week.
Responsibilities
Provide strategic leadership and operational oversight of global pharmacovigilance (PV) and drug safety programs for marketed and investigational products.
Ensure regulatory compliance, risk management, clinical trial safety oversight, cost-effective vendor management, and adherence to highest industry standards.
Direct all aspects of PV operations and ensure compliance with FDA, EMA, Health Canada, and ICH GVP regulations.
Conduct medical review and analysis of individual case safety reports (ICSRs) and aggregate reports (e.g., PADERs, PSURs, DSURs).
Lead signal detection, risk assessment, and ensure prompt identification and mitigation of potential safety concerns.
Collaborate with clinical development teams to provide safety input on study protocols, investigator brochures, statistical analysis plans, and informed consent forms.
Oversee safety data collection, reconciliation, and analysis in clinical trials to ensure regulatory compliance.
Provide guidance in Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS).
Serve as primary liaison with FDA, EMA, and other regulatory agencies; prepare responses to inquiries and ensure ongoing compliance.
Ensure audit and inspection readiness; provide strategic oversight for FDA, EMA, and Health Canada inspections.
Develop and oversee SOPs and Pharmacovigilance Agreements (PVAs) for compliance with global safety regulations.
Negotiate pharmacovigilance vendor contracts to reduce costs while ensuring quality and regulatory compliance.
Oversee vendor performance and ensure adherence to Safety Data Exchange Agreements (SDEAs) and pharmacovigilance requirements.
Coordinate with QA teams to conduct Health Hazard Evaluations (HHEs) for post-marketing products and assess potential safety risks.
Ensure timely and accurate reporting of post-marketing safety signals; collaborate with regulatory agencies as needed.
Manage and mentor pharmacovigilance professionals for continuous training and career development.
Provide strategic direction to cross-functional teams across Clinical, Regulatory, and Medical Affairs departments.
May undergo background checks including drug testing/screening.
Requirements
Must have Doctor of Medicine degree in Medical or Pharmaceutical Sciences.
15 years of relevant experience in global pharmacovigilance and drug safety with direct oversight of FDA, EMA, and Health Canada regulatory requirements.
Skills (15 years of experience): 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 on drug safety matters.
Additional experience (10 years): leading in clinical trial safety, regulatory inspections, and post-marketing surveillance; developing and overseeing Risk Management Plans (RMPs) and REMS for marketed products; experience with ADHD, pain management, addiction, and CNS disorder products; working with Argus and ARISg safety databases including data migration.
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