EU QPPV Lead — Pharmacovigilance & Compliance (Amsterdam)

OCUGEN OPCO INC; Amsterdam; On-site; EUR 140,000 - 190,000; Full time

Job summary

Ocugen Netherlands B.V. seeks an experienced EU QPPV to build and maintain a compliant European pharmacovigilance system, supporting clinical development, regulatory submissions, and future commercialization.

You will establish PV governance, oversight, and quality systems in line with EMA GVP, and partner with Regulatory Affairs, Clinical Development, Quality, Medical Affairs and Commercial teams to embed patient safety across the product lifecycle.

Qualifications

• Advanced degree in Pharmacy, Medicine, Life Sciences or related field.
• 7–10 years of progressive pharmacovigilance or drug safety experience in biotech/pharma.
• Experience supporting EMA pharmacovigilance activities and regulatory submissions.
• Experience implementing PV processes, systems, and vendor oversight.
• Experience with regulatory inspections and audits.

Responsibilities

• Lead European pharmacovigilance activities and ensure EMA GVP compliance.
• Develop and maintain PV System Master File (PSMF) and procedures.
• Ensure inspection readiness and adapt to evolving regulatory requirements.
• Support regulatory submissions, MAAs, and lifecycle management.
• Collaborate with Regulatory, Clinical Operations, Quality, and Medical Affairs.

Skills

Pharmacovigilance leadership

Regulatory collaboration

Vendor oversight

Cross-functional collaboration

EMA/GVP experience

Education

Advanced degree in Pharmacy/Medicine/Life Sciences

Advanced degree (MS/PhD) preferred

Job description

Ocugen Netherlands B.V. seeks an experienced EU QPPV to build and maintain a compliant European pharmacovigilance system, supporting clinical development, regulatory submissions, and future commercialization.

You will establish PV governance, oversight, and quality systems in line with EMA GVP, and partner with Regulatory Affairs, Clinical Development, Quality, Medical Affairs and Commercial teams to embed patient safety across the product lifecycle.