Qualified Person for Pharmacovigilance

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

Job Details: Job Location: Amsterdam - Amsterdam, About Ocugen Netherlands B.V.

Ocugen Netherlands B.V. is the European subsidiary of Ocugen, Inc., a U.S.-based biotechnology company focused on developing innovative gene and cell therapies and vaccines to improve patients’ lives. Our work includes advancing novel treatments for serious retinal diseases with significant unmet medical needs.

We are establishing our European operations in Amsterdam to support clinical development, regulatory activities, and future commercialization. Joining our growing team offers the opportunity to help build our European presence, collaborate with colleagues across the United States and internationally, and contribute to bringing potentially transformative therapies to patients.

This position is based onsite at our Amsterdam office, with in-office attendance expected.

Position Summary

This role is responsible for developing and maintaining a compliant European pharmacovigilance system that supports clinical development, regulatory submissions, and future commercialization. The QPPV will establish pharmacovigilance infrastructure, governance, and quality systems, ensure compliance with European Medicines Agency (EMA) Good Pharmacovigilance Practices (GVP), and partner closely with Regulatory Affairs, Clinical Development, Quality, Medical Affairs, and Commercial teams to integrate patient safety throughout the product lifecycle.

As Ocugen expands its European presence, the QPPV will develop scalable pharmacovigilance capabilities that support multiple product approvals, commercialization, and continued organizational growth.

Responsibilities

Pharmacovigilance Leadership

• Serve as Ocugen's designated EU Qualified Person for Pharmacovigilance (QPPV), ensuring compliance with applicable European pharmacovigilance regulations.
• Establish, implement, and maintain the Company's European pharmacovigilance system in accordance with EMA Good Pharmacovigilance Practices (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.

Patient Safety & Regulatory Support

• Support European clinical development programs by providing pharmacovigilance oversight and safety expertise.
• Partner with Regulatory Affairs to support Marketing Authorization Applications (MAAs), lifecycle management activities, and regulatory authority interactions.
• Contribute to Risk Management Plans (RMPs), Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs), and other regulatory safety submissions.
• Monitor emerging safety information and support benefit-risk evaluations throughout product development and commercialization.

Operational Management

• Manage day-to-day European pharmacovigilance activities, including oversight of safety reporting processes and regulatory compliance.
• Manage pharmacovigilance vendors, CROs, and external service providers to ensure high-quality and compliant operations.
• Establish pharmacovigilance metrics, quality oversight, and continuous process improvements.
• Support internal audits, regulatory inspections, and implementation of corrective and preventive actions (CAPAs), as applicable.

Cross-Functional Collaboration

• Partner closely with the General Manager and collaborate with Regulatory Affairs, Clinical Operations, Quality, Medical Affairs, and Global Drug Safety to integrate patient safety throughout the product lifecycle.
• Support the development of scalable pharmacovigilance processes that align with Ocugen's European growth and commercialization plans.
• Provide pharmacovigilance guidance to internal stakeholders on applicable European safety requirements and best practices.

Qualifications

• Advanced degree in Pharmacy (PharmD), Medicine (MD), Life Sciences, Nursing, or a related scientific discipline required.
• Advanced degree (MS, PhD, or equivalent) preferred.
• 7–10 years of progressive pharmacovigilance or drug safety experience within the biotechnology or pharmaceutical industry.
• Experience supporting European pharmacovigilance activities and working within the EMA regulatory environment.
• Experience supporting clinical development programs, regulatory submissions, and pharmacovigilance compliance.
• Experience implementing and maintaining pharmacovigilance processes, systems, and vendor oversight.
• Experience supporting regulatory inspections and audits.
• Prior experience serving as, or supporting, an EU QPPV is preferred.
• Experience in biologics, gene therapy, cell therapy, ATMPs, or rare diseases is preferred.

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer.

In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance.

We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law.

Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.