Vice President, Head of Global Patient Safety & Risk Management
Disc Medicine
July 02, 2026
Remote friendly (United States)
United States
Medical Affairs
POSITION OVERVIEW
- Develop and oversee global pharmacovigilance (PV) and drug safety strategy for small molecules and mAbs; lead safety strategy and pre-/post-marketing safety operations; ensure global regulatory compliance; partner cross-functionally to foster a culture of safety.
RESPONSIBILITIES
- Represent the safety function as an SME and strategic partner to leadership and development/filing teams.
- Integrate patient safety & risk management across development programs.
- Develop and execute safety governance and surveillance processes.
- Oversee medical safety and risk management across the portfolio, including safety signal surveillance, benefit-risk assessments, and risk mitigation.
- Serve 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; represent safety in Data Monitoring Committees and other governance forums.
- Oversee medical review and submission of ICSRs.
- Lead responses to regulatory safety questions and represent safety in regulatory interactions.
- Review safety data as SME for public presentations and publications.
- Oversee PV vendor oversight, safety systems, database reconciliation, inspection readiness, and PV-related regulatory submission activities.
- Ensure timely submissions of expedited reports, DSURs, PBRERs, and other safety deliverables.
- Lead inspections/audits as primary safety representative and ensure corrective actions.
- Develop scalable, compliant safety and risk management processes with PV operations.
- Ensure compliance with FDA, EMA, ICH, and global pharmacovigilance requirements.
- Build, mentor, 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/pharmacovigilance experience in biotech/pharma; at least 5 years in leadership/management.
- Deep expertise in safety surveillance, signal/risk management, benefit-risk assessment, and global safety reporting across all clinical phases.
- Mastery of FDA, EMA, GVP, and ICH; experience supporting NDA, BLA and/or MAA filings and global health authority interactions.
- Develop and oversee global pharmacovigilance (PV) and drug safety strategy for small molecules and mAbs; lead safety strategy and pre-/post-marketing safety operations; ensure global regulatory compliance; partner cross-functionally to foster a culture of safety.
RESPONSIBILITIES
- Represent the safety function as an SME and strategic partner to leadership and development/filing teams.
- Integrate patient safety & risk management across development programs.
- Develop and execute safety governance and surveillance processes.
- Oversee medical safety and risk management across the portfolio, including safety signal surveillance, benefit-risk assessments, and risk mitigation.
- Serve 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; represent safety in Data Monitoring Committees and other governance forums.
- Oversee medical review and submission of ICSRs.
- Lead responses to regulatory safety questions and represent safety in regulatory interactions.
- Review safety data as SME for public presentations and publications.
- Oversee PV vendor oversight, safety systems, database reconciliation, inspection readiness, and PV-related regulatory submission activities.
- Ensure timely submissions of expedited reports, DSURs, PBRERs, and other safety deliverables.
- Lead inspections/audits as primary safety representative and ensure corrective actions.
- Develop scalable, compliant safety and risk management processes with PV operations.
- Ensure compliance with FDA, EMA, ICH, and global pharmacovigilance requirements.
- Build, mentor, 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/pharmacovigilance experience in biotech/pharma; at least 5 years in leadership/management.
- Deep expertise in safety surveillance, signal/risk management, benefit-risk assessment, and global safety reporting across all clinical phases.
- Mastery of FDA, EMA, GVP, and ICH; experience supporting NDA, BLA and/or MAA filings and global health authority interactions.