Executive Director, Safety & Pharmacovigilance

Responsibilities

• Define and lead the global safety and pharmacovigilance strategy across all development stages.
• Serve as the safety subject-matter expert for cell therapy programs, including novel and emerging safety risks.
• Provide strategic safety input to clinical development plans, protocols, investigator brochures, and regulatory submissions.
• Act as a key member of cross-functional governance and program teams.
• Oversee all PV activities including case processing, signal detection, risk management, and aggregate reporting.
• Ensure compliant execution of ICSR reporting, DSURs, PBRERs/PSURs, SUSARs, and safety narratives.
• In collaboration with other team members, maintain safety databases, vendor oversight, and PV agreements (SDEAs).
• Lead safety surveillance activities and ongoing benefit-risk assessments.
• Review and approve safety data, medical assessments, and regulatory safety documents.
• Contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and internal safety governance forums.
• Lead safety signal evaluation, escalation, and documentation.
• Ensure compliance with global safety regulations (FDA, EMA, ICH, CIOMS, local health authorities).
• Partner with team lead for regulatory interactions, inspections, and audits.
• Author or oversee safety sections of INDs and BLAs, and responses to health authority inquiries.
• Partner with team members to maintain PV SOPs, processes, and inspection readiness.
• Lead development and lifecycle management of Risk Management Plans (RMPs) and REMS, as applicable.
• Proactively identify and mitigate safety risks associated with cell therapy modalities.
• Support post-marketing safety planning and launch readiness, where applicable.
• Collaborate in the management of external vendors, CROs, and safety service providers.
• Contribute to the operational excellence, continuous improvement, and cost-effective PV operations.

Qualifications

• MD degree
• 12+ years of experience in pharmacovigilance and drug safety, with at least 5 years in a leadership role.
• Direct experience supporting cell therapy, gene therapy, or other advanced modalities strongly preferred.
• Experience in clinical-stage biotech; prior BLA/MAA and/or launch experience is a plus.
• Demonstrated success interacting with global regulatory agencies on safety matters.
• Strong knowledge of global PV regulations and safety standards.
• Strategic thinker with the ability to operate hands-on in a lean organization.
• Excellent cross-functional leadership and communication skills.
• Proven ability to balance compliance, scientific rigor, and business priorities.