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Job Description

The Head of Safety and Pharmacovigilance – Cell Therapy leads a specialized and expanding global team of scientists and clinicians dedicated to advancing safety across the cell therapy portfolio. This executive role is responsible for setting the strategic direction, governance, and operational execution of safety and pharmacovigilance activities for both investigational and marketed products.

Reporting to the SVP, Development, the Head of Safety and Pharmacovigilance is a key member of the Development Leadership Team and participates in cross-functional and executive-level forums. This leader ensures global regulatory alignment, scientific excellence, and operational rigor in all safety-related activities, while fostering a culture of proactive risk management, compliance, and continuous improvement.

Key Responsibilities

Strategic Leadership

• Define and execute a comprehensive global safety and pharmacovigilance strategy aligned with corporate objectives and regulatory expectations.

• Represent the safety function in senior leadership forums, cross-functional governance bodies, and external engagements with regulatory authorities and partners.

• Champion a culture of safety, scientific integrity, and innovation across the organization.

Pharmacovigilance Operations

• Oversee global PV systems and processes, including case processing, signal detection, aggregate reporting, and benefit-risk assessments.

• Ensure timely and accurate safety data collection, evaluation, and reporting in compliance with international regulations (e.g., FDA, EMA, PMDA).

• Lead inspection readiness and manage responses to audits and regulatory inquiries.

Regulatory Compliance and Governance

• Serve as the primary liaison with global regulatory agencies on safety matters.

• Ensure compliance with Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), and other applicable standards.

• Lead the development and maintenance of SOPs, safety governance frameworks, and CAPA programs.

Risk Management and Safety Science

• Lead the identification, assessment, and mitigation of safety risks across the product lifecycle.

• Drive the development of risk management plans and safety specifications for regulatory submissions.

• Promote the use of advanced analytics and real-world evidence to enhance safety signal detection and decision-making.

Cross-Functional Collaboration

• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and Manufacturing to ensure integrated safety oversight.

• Collaborate with external partners, CROs, and affiliates to ensure consistent safety practices and reporting.

Team Leadership and Development

• Build and lead a high-performing global safety and PV team.

• Provide mentorship, career development, and performance management for team members.

• Foster a culture of accountability, collaboration, and continuous learning.

Innovation and Research

• Stay abreast of emerging trends in cell therapy, safety science, and regulatory policy.

• Support research initiatives aimed at improving patient outcomes and advancing safety methodologies.

Qualifications

• Advanced degree in medicine, pharmacy, or life sciences (MD, PharmD, PhD preferred).

• 10+ years of experience in pharmacovigilance, drug safety, or related regulatory roles in the biopharmaceutical industry.

• Proven leadership in global safety strategy, PV operations, and regulatory engagement.

• Deep understanding of cell therapy modalities and associated safety challenges.

• Strong analytical, strategic thinking, and communication skills.

• Demonstrated ability to lead cross-functional teams and influence at all levels of the organization.

People Leader Accountabilities

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