Director, Patient Safety & Pharmacovigilance

OCUGEN OPCO INC; Malvern (Chester County); On-site; USD 180,000 - 240,000; Full time

Job summary

OCUGEN OPCO INC is seeking a Director of Pharmacovigilance & Patient Safety to lead safety surveillance across its ocular gene therapy portfolio. The role includes medical review of adverse events, safety signal detection, aggregate reporting, vendor oversight, and inspection readiness.

The candidate will collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and QA to ensure timely safety actions and regulatory compliance across the program.

Qualifications

• MD or DO strongly preferred.
• 7+ years of pharmacovigilance or drug safety in biotech/pharma.
• Experience authoring DSURs, IND annual reports, Investigator Brochure safety sections, regulatory responses.

Responsibilities

• Serve as safety physician for assigned programs; assess safety events.
• Review and approve SAEs, SUSARs, AESIs and pregnancy cases.
• Evaluate safety data; identify signals; recommend follow-up actions.
• Lead benefit–risk assessments and communicate to cross-functional teams.
• Provide safety input to protocols, ICFs, and study reports.
• Oversee PV documentation; maintain safety surveillance plans and DSUR safety updates.

Skills

Pharmacovigilance

Leadership

Medical judgement

Cross-functional collaboration

Education

MD or DO

Tools

Argus

ArisGlobal LifeSphere

Job description

OCUGEN OPCO INC is seeking a Director of Pharmacovigilance & Patient Safety to lead safety surveillance across its ocular gene therapy portfolio. The role includes medical review of adverse events, safety signal detection, aggregate reporting, vendor oversight, and inspection readiness.

The candidate will collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and QA to ensure timely safety actions and regulatory compliance across the program.