Data Officer – Pharmacovigilance

About the role

ProductLife Group is seeking a motivated Data Officer to support its pharmacovigilance hub. You will be responsible for accurate data handling, regulatory submissions, and the preparation of safety documentation, ensuring compliance with global drug‑safety standards.

Key responsibilities

• Enter vigilance cases into relevant pharmacovigilance databases.
• Prepare initial emails and clarification requests for follow‑up activities.
• Submit safety cases to competent authorities.
• Run specific database queries to draft safety reports.
• Monitor and download Individual Case Safety Reports (ICSRs) from national portals such as Eudravigilance and the MHRA.
• Maintain and update records in the XEVMPD system.
• Draft and revise technical agreements, safety management plans, and client templates.
• Create and update SOPs, work‑process documents, and training materials.
• Participate in the implementation, maintenance, and continuous improvement of pharmacovigilance processes.

Required profile

• Bachelor’s degree in Science, Industrial Biology, Chemistry, or Engineering.
• Minimum 2 years of experience in pharmacovigilance, preferably with a service‑provider focused on data entry and quality control.
• Proven ability to work under tight deadlines and manage client communications.
• Strong knowledge of EU pharmacovigilance regulations, GVP, GCP, FDA requirements, and drug‑safety principles.
• Deep understanding of adverse‑event reporting and causality assessment.

Required skills

• Database management experience.
• Familiarity with Eudravigilance, MHRA portal, and XEVMPD systems.

What we offer

• Opportunity to work within a dynamic, international safety team.
• Professional development in drug‑safety and regulatory affairs.