Director, Pharmacovigilance

About the role

This role can be based out of our Philadelphia, PA headquarters, hybrid, or remote.

Responsibilities

• Lead pharmacovigilance strategy across clinical programs, ensuring alignment with overall clinical development plans.
• Serve as the safety lead on study teams, providing medical and scientific input on safety data interpretation and risk management.
• Contribute to the development and maintenance of safety-related documents, including DSURs, IBs, protocols, and safety sections of regulatory submissions (e.g., INDs/BLAs).
• Oversee case processing activities, including SAE review, medical assessment, and timely reporting in compliance with global regulations.
• Lead signal detection, evaluation, and risk assessment activities, including aggregate data review and benefit-risk evaluation.
• Ensure appropriate escalation and communication of safety signals to internal stakeholders and governance committees.
• Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines.
• Support health authority interactions related to safety and pharmacovigilance.
• Contribute to inspection readiness activities and support audits and inspections as needed.
• Partner closely with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs to ensure integrated safety oversight across programs.
• Provide safety input into clinical trial design, study conduct, and data review processes.
• Collaborate with external vendors (e.g., CROs, safety databases) to ensure high-quality PV operations.
• Establish and refine pharmacovigilance processes, systems, and infrastructure to support a growing clinical pipeline.
• Oversee PV vendors and ensure performance, quality, and compliance.
• Contribute to building scalable PV capabilities in preparation for late-stage development and potential commercialization.

Qualifications

• Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical discipline preferred.
• Minimum of 8–10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry, including clinical-stage programs.
• Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH).
• Experience supporting clinical trials, including safety monitoring, signal detection, and aggregate reporting (e.g., DSURs).
• Prior experience in cell and gene therapy, immunology, or related therapeutic areas strongly preferred.
• Demonstrated ability to work cross-functionally and influence without authority in a matrixed environment.
• Proven ability to operate both strategically and hands-on in a fast-paced, resource-constrained setting.
• Experience working in or with early-stage or growth-stage biotech companies preferred.
• Excellent analytical, communication, and problem-solving skills.
• Strong attention to detail and commitment to quality and patient safety.