Freelance Pharmacovigilance Manager (Estonia)

About the role

An experienced Local Pharmacovigilance (PV) Specialist is sought, based in Estonia, to provide local PV support and ensure compliance with national and European requirements. The contractor supports safety reporting, regulatory intelligence, literature screening and LPPV duties. The workload is about 5-6 hours per month.

Key responsibilities

• Prepare monthly PV metrics reports and reconciliations
• Conduct regulatory PV intelligence and monitor local regulatory updates
• Perform local literature screening (LLS)
• Provide LPPV services, including PV management and monitoring of the PV mailbox
• Deliver initial and periodic PV training, including PV agreements (PvA) and product materials
• Take part in meetings with the QPPV and other stakeholders
• Support regulatory inspections and audits, and deliver PV training to the client where required
• Support aRMMs and DHPCs, and assist with ICSR processing and follow-up
• Coordinate translations, quality check them, and support nominations and notifications to the Health Authority
• Provide ad hoc PV support as needed

Required profile

• Previous PV experience, preferably in the pharmaceutical industry
• Knowledge of Estonian PV regulations and the local Health Authority's requirements
• Experience with LPPV duties or local PV management
• Fluency in Estonian and proficiency in English
• Ability to work independently as a freelance contractor

Required skills

• Understanding of EU PV regulations and GVP guidelines
• Local literature screening and ICSR processing