EU QPPV | Pharmacovigilance Leadership in Biotech

Ocugen; Amsterdam; On-site; EUR 90,000 - 140,000; Full time

Job summary

Ocugen Netherlands B.V. is seeking a qualified QPPV to develop and maintain a compliant European pharmacovigilance system supporting clinical development, regulatory submissions, and future commercialization.

You will lead EU pharmacovigilance, ensure EMA GVP compliance, maintain PSMF, and partner with Regulatory Affairs, Clinical Development, Quality, Medical Affairs, and Commercial teams to integrate patient safety.

Qualifications

• 7–10 years of progressive pharmacovigilance or drug safety experience.
• Experience supporting European pharmacovigilance activities within EMA regulatory environment.
• Experience supporting clinical development programs, regulatory submissions, and pharmacovigilance compliance.
• Experience implementing and maintaining pharmacovigilance processes, systems, and vendor oversight.
• Prior experience as, or supporting, an EU QPPV is preferred.
• Experience in biologics, gene therapy, ATMPs, or rare diseases is preferred.

Responsibilities

• Serve as Ocugen's designated EU Qualified Person for Pharmacovigilance (QPPV), ensuring compliance with applicable European pharmacovigilance regulations.
• Establish, implement, and maintain the European pharmacovigilance system in accordance with EMA GVP.
• Develop and maintain the Pharmacovigilance System Master File (PSMF) and support pharmacovigilance procedures.
• Ensure the pharmacovigilance system remains inspection-ready and compliant with evolving regulatory requirements.

Skills

Pharmacovigilance

Drug safety

Vendor oversight

Regulatory collaboration

Education

Advanced degree in Pharmacy or Medicine or Life Sciences

Advanced degree (MS/PhD) preferred

Job description

Ocugen Netherlands B.V. is seeking a qualified QPPV to develop and maintain a compliant European pharmacovigilance system supporting clinical development, regulatory submissions, and future commercialization.

You will lead EU pharmacovigilance, ensure EMA GVP compliance, maintain PSMF, and partner with Regulatory Affairs, Clinical Development, Quality, Medical Affairs, and Commercial teams to integrate patient safety.