• 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.