EU-QPPV; Pharmacovigilance Manager Pharmacovigilance Team Europe | Hybrid

Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.

As we continue to grow, we are looking for an experienced and skilled EU-QPPV (Pharmacovigilance Manager) to oversee pharmacovigilance systems for our clients and ensure regulatory compliance across European markets.

• Fulfill the obligations of the QPPV as per EU & UK regulatory requirements and Good Pharmacovigilance Practice (GVP) guidelines.
• Oversee the pharmacovigilance systems maintained by Insuvia for its clients, ensuring compliance, robustness, and inspection‑readiness.
• Advise clients on best practices and strategic decisions related to PV operations, compliance, and continuous improvement.
• Act as the main point of contact for EU competent authorities and the EMA for client products, ensuring 24/7 availability.
• Ensure the PSMF is created, maintained, and kept up to date for each client, reflecting the current status of the PV system and available for inspection at all times.
• Maintain oversight of the safety profiles of client products, including signal detection, risk minimisation measures, and post‑authorisation safety activities.
• Ensure timely preparation and submission of key safety documents (e.g., PSURs, RMPs, responses to health authorities).
• Represent clients during audits and inspections, and provide expert input throughout audit readiness, execution, and follow‑up phases.
• Collaborate closely with internal PV colleagues and project teams to ensure consistency, high quality, and smooth client delivery.

• Eligible to be registered as an EU QPPV.
• University degree in life sciences (MD, Pharmacist, or equivalent degree).
• At least 5 years of EU PV experience, including prior experience as a QPPV or Deputy QPPV.
• Strong understanding of PV systems, EU & UK regulatory frameworks, and GVP requirements.
• Experience working with or advising pharmaceutical or biotech companies, ideally in a service provider or consultancy setting.
• Strong interpersonal skills and a client‑focused mindset.
• Fluent in English (written and spoken).

• Engaging, dynamic and diverse work in a young and rapidly growing company.
• International and multicultural environment.
• Workplace where your input matters and has an impact.
• Broad opportunities for self‑expression and professional growth.
• Adequate workload, work‑life balance and flexibility.