Senior Director, Safety & Pharmacovigilance

OCUGEN OPCO INC; Malvern (AR); 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 activities across its ocular gene therapy portfolio. The role involves medical review, signal detection, risk assessment, and regulatory reporting.

Responsibilities include overseeing PV operations, authoring safety documents, and ensuring inspection readiness in a fast-paced biotech environment.

Qualifications

• MD or DO strongly preferred.
• 7+ years of pharmacovigilance or drug safety experience in biotech/pharma.
• Experience authoring DSURs, annual reports, and safety sections.

Responsibilities

• Serve as safety physician for assigned programs; assess SAEs, SUSARs, AESIs.
• Review safety data, evaluate signals, and recommend follow-up actions.
• Lead benefit-risk assessments and communicate to cross-functional teams.

Skills

MD/DO preferred

PV/Drug Safety

Safety leadership

Regulatory knowledge

Cross-functional collaboration

Quality & compliance

Tools

Argus

ArisGlobal LifeSphere

Job description

OCUGEN OPCO INC is seeking a Director of Pharmacovigilance & Patient Safety to lead safety activities across its ocular gene therapy portfolio. The role involves medical review, signal detection, risk assessment, and regulatory reporting.

Responsibilities include overseeing PV operations, authoring safety documents, and ensuring inspection readiness in a fast-paced biotech environment.