Executive Director, Safety & Pharmacovigilance
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Job Description
Executive Director of Safety & Pharmacovigilance overseeing global safety strategy for cell therapy pipeline. Leading a compliant and scalable safety organization, ensuring proactive risk management and regulatory compliance.
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.
Requirements:
- 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.
Benefits:
- Bonus
- Benefits
- Participation in the company’s stock plan
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