purple ellipse
< BACK

EU Qualified Person for Pharmacovigilance (EU-QPPV) 

The EU-QPPV is responsible for ensuring compliance with EU pharmacovigilance regulations and maintaining the safety profile of Oculis products marketed in the European Union. He/ She serve as a backup to the Global Head of Pharmacovigilance (PV), providing leadership continuity and oversight of Global PV operations. The EU-QPPV has hands-on role in key safety deliverables, act as the primary contact for EU regulatory authorities and host EMA or FDA inspections.

Reports To: Global Head of Pharmacovigilance 
Function: Research & Development
Level: Director
Location: EU (France or Spain)

Key Responsibilities: 

1. Regulatory Compliance & Oversight 

  • Ensure compliance with EU pharmacovigilance legislation and GVP requirements.
  • Act as the legally mandated EU-QPPV contact for Competent Authorities and ensure timely communication of safety concerns.
  • Maintain oversight of the Pharmacovigilance System Master File (PSMF) and ensure its accuracy and currency.
  • Ensure all Pharmacovigilance Agreements (PVAs) with partners and distributors are in place, compliant, and up to date.
  • Maintain 24/7 availability as the primary contact for EU Competent Authorities.
  • May act as the local pharmacovigilance contact person for national compliance in France (if located in France).

2. Operational Support 

  • Serve as a backup to the Global Head of Pharmacovigilance, providing leadership continuity, oversight of outsourced PV activities/PV vendors, and operational support.
  • Collaborate closely with the Global PV Head on risk minimization strategies.
  • Participate in global safety governance committees and decision-making processes.
  • Review and approve Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs), and Pharmacovigilance System Master File (PSMF).
  • Ensure timely and compliant submission of aggregate safety reports (PBRER, RMP) and risk management documentation.
  • Contribute to signal detection and signal management activities including active participation to the Safety Management Team (SMT) and Global PV Committee (GPVC) meetings.
  • Ensure timely communication of safety concerns to Competent Authorities.

3. Inspection Readiness & Hosting 

  • Act as the host during EMA and FDA inspections, ensuring readiness and effective communication with Competent Authorities.
  • Lead preparation for audits and inspections, ensuring robust documentation and compliance.
  • Review and approve PV deviation reports and CAPAs, ensuring effective root-cause analysis and timely closure.

4. System & Vendor Management 

  • Ensure PV systems and processes are validated and audit-ready.
  • Oversee PV vendors and CROs for compliance with contractual obligations.

5. Cross-Functional Collaboration 

  • Work with clinical operations, clinical development, regulatory affairs, medical affairs, quality, manufacturing/CMC, legal, and marketing teams to integrate safety considerations across the product lifecycle.
  • Act as the regional EU-PV lead to align processes and ensure global compliance.
  • Provide expert guidance on EU-specific pharmacovigilance requirements to internal stakeholders.
  • Provide PV training to internal teams and maintain awareness of regulatory changes.

Necessary Skill Set:  

  • Minimum 8–10 years of experience in pharmacovigilance, including a senior PV role.
  • Experience in ophthalmology is a plus.
  • The QPPV shall reside and operate in the EU [DIR 2001/83/EC, Art 104 (3)]. Following European Economic Area (EEA) agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein.
  • Proven ability to interact with FDA and EMA Competent Authorities and manage complex safety deliverables.
  • Experience with late-stage clinical development preferred.
  • Entrepreneurial, hands-on mindset with strong problem-solving skills.
  • In-depth theoretical and practical knowledge of pharmacovigilance activities (IR (EU) 520/2012, Art. 10(1)).
  • Skills for the management of pharmacovigilance systems. 
  • Excellent communication skills to collaborate with internal and external stakeholders. 
  • Experience with safety databases (e.g., Argus).
  • Proficiency in risk management methodologies.
  • Ability to manage complex projects and prioritize effectively.

Education

  • Bachelor’s degree in a relevant field (e.g. pharmacy, life sciences, medicine).
  • Advanced degree (e.g. PharmD, MD, PhD) preferred.
  • Holding a formal education in ophthalmology is considered a strong advantage.

Oculis SA is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply.

Click here to apply