Remote QPPV Lead - Pharmacovigilance Expert

PrimeVigilance Ltd.; Madrid; On-site; EUR 110,000 - 170,000; Full time

Job summary

PrimeVigilance Ltd. is seeking an EU QPPV to lead the pharmacovigilance function. The role focuses on establishing and maintaining safety information systems, responding to regulatory requests, and providing timely safety data for post‑authorisation activities.

You will oversee product safety, ensure regulatory compliance across EU jurisdictions, and work with CAs, MAHs, and internal teams to ensure high-quality safety oversight.

Qualifications

• PV system operations knowledge
• Strong knowledge of global regulations and safety reporting standards
• Proven leadership in PV projects or functions
• Extensive PV experience with senior QPPV responsibilities

Responsibilities

• Establish and maintain a PV information system accessible across the Community.
• Respond promptly to CA requests for additional safety information.
• Provide regulatory bodies with relevant safety information including post‑authorisation studies.
• Maintain continuous availability to CAs, the Agency, and MAH with backup procedures.
• Oversee safety profiles and commitments related to product safety.

Skills

PV system operations knowledge

Global regulatory knowledge

English communication

Education

Medicine or Pharmacy degree

Job description

PrimeVigilance Ltd. is seeking an EU QPPV to lead the pharmacovigilance function. The role focuses on establishing and maintaining safety information systems, responding to regulatory requests, and providing timely safety data for post‑authorisation activities.

You will oversee product safety, ensure regulatory compliance across EU jurisdictions, and work with CAs, MAHs, and internal teams to ensure high-quality safety oversight.