Vice President, Head of Global Patient Safety & Risk Management
Disc Medicine
August 14, 2026
Remote friendly (United States)
United States
Medical Affairs
Responsibilities:
- Develop and execute the global drug safety and pharmacovigilance (PV) strategy for small molecules and mAbs; lead pre- and post-marketing safety operations.
- Serve as safety SME and partner to executives, stakeholders, and development/filing teams; integrate patient safety and risk management across development programs.
- Establish safety governance and surveillance processes; oversee safety signal surveillance, benefit-risk assessments, and risk mitigation.
- Act as patient safety/risk management SME for key documents (IBs, protocols, Integrated Summary of Safety, RMPs, Safety Surveillance Plans, Reference Safety Information, CCDS/PIs).
- Oversee commercial safety monitoring and product launch readiness.
- Chair safety governance committees and represent safety in Data Monitoring Committees and other governance forums.
- Oversee medical review and submission of ICSRs; lead responses to regulator safety questions; represent safety in regulatory interactions.
- Review safety data as SME for public presentations and publications.
- Oversee PV operations and compliance: vendor oversight, process development, safety systems, database reconciliation, inspection readiness, and safety submission activities.
- Ensure timely submission of expedited reports, DSURs, PBRERs, and other regulatory safety deliverables.
- Ensure inspection/audit readiness and effective corrective actions.
- Build and scale patient safety/risk management organization; develop operating plans, budgets, and resource strategies; manage internal/external PV resources.
Requirements:
- MD preferred; PharmD/PhD (or equivalent advanced sciences) encouraged.
- 15–20 years progressive drug safety/PV experience in biotech/pharma; 5+ years in leadership/management.
- Deep expertise in safety surveillance, signal/risk management, benefit-risk assessment, global safety reporting, and aggregate reports.
- Mastery of FDA, EMA, GVP, and ICH regulations; experience supporting NDA/BLA/MAA submissions and global health authority interactions.
- Develop and execute the global drug safety and pharmacovigilance (PV) strategy for small molecules and mAbs; lead pre- and post-marketing safety operations.
- Serve as safety SME and partner to executives, stakeholders, and development/filing teams; integrate patient safety and risk management across development programs.
- Establish safety governance and surveillance processes; oversee safety signal surveillance, benefit-risk assessments, and risk mitigation.
- Act as patient safety/risk management SME for key documents (IBs, protocols, Integrated Summary of Safety, RMPs, Safety Surveillance Plans, Reference Safety Information, CCDS/PIs).
- Oversee commercial safety monitoring and product launch readiness.
- Chair safety governance committees and represent safety in Data Monitoring Committees and other governance forums.
- Oversee medical review and submission of ICSRs; lead responses to regulator safety questions; represent safety in regulatory interactions.
- Review safety data as SME for public presentations and publications.
- Oversee PV operations and compliance: vendor oversight, process development, safety systems, database reconciliation, inspection readiness, and safety submission activities.
- Ensure timely submission of expedited reports, DSURs, PBRERs, and other regulatory safety deliverables.
- Ensure inspection/audit readiness and effective corrective actions.
- Build and scale patient safety/risk management organization; develop operating plans, budgets, and resource strategies; manage internal/external PV resources.
Requirements:
- MD preferred; PharmD/PhD (or equivalent advanced sciences) encouraged.
- 15–20 years progressive drug safety/PV experience in biotech/pharma; 5+ years in leadership/management.
- Deep expertise in safety surveillance, signal/risk management, benefit-risk assessment, global safety reporting, and aggregate reports.
- Mastery of FDA, EMA, GVP, and ICH regulations; experience supporting NDA/BLA/MAA submissions and global health authority interactions.