Homebased QPPV Lead – Pharmacovigilance (EU/UK)

Ergomed Group; Lisboa; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

PrimeVigilance, part of Ergomed Group, is seeking a Qualified Person Responsible for Pharmacovigilance (QPPV) for EU and UK operations in a homebased role. You will lead PV system oversight, ensure regulatory compliance and act as primary contact for competent authorities.

The successful candidate will bring extensive PV experience, knowledge of global pharmacovigilance regulations, strong leadership, and fluency in English.

Qualifications

• Life-science education background (Medicine or Pharmacy) preferred.
• Solid knowledge of PV system operations and function.
• Strong knowledge of global regulations, standards and best practices for safety processing and reporting in post-marketing.
• Strong operational and managerial skills demonstrated by leading projects or functions.
• Strong experience in a PV role, proven track record as QPPV.
• Strong oral and written English communication skills.

Responsibilities

• Establish and maintain a PV information system accessible within the EU/UK community.
• Ensure prompt and complete responses to requests from Competent Authorities for safety data.
• Provide relevant safety information to authorities, including post-authorisation safety study plans.
• Maintain continuous availability to Competent Authorities and MAHs with robust back-up procedures.

Skills

PV system operations

Regulatory knowledge

Management experience

English proficiency

Education

Life-science degree (Medicine or Pharmacy)

Job description

PrimeVigilance, part of Ergomed Group, is seeking a Qualified Person Responsible for Pharmacovigilance (QPPV) for EU and UK operations in a homebased role. You will lead PV system oversight, ensure regulatory compliance and act as primary contact for competent authorities.

The successful candidate will bring extensive PV experience, knowledge of global pharmacovigilance regulations, strong leadership, and fluency in English.