Pharmacovigilance Specialist

About the role

Pharmabide Ltd, a Pharmaceutical Consulting Company with more than 20 years presence in the European market, is seeking a Pharmacovigilance Specialist to join its Pharmacovigilance department. The successful candidate will be involved in a broad range of pharmacovigilance activities, supporting pharmaceutical companies and Marketing Authorisation Holders (MAHs) and gaining hands‑on experience across different products, clients and pharmacovigilance systems.

Key responsibilities

• Management, processing, follow‑up and quality review of Individual Case Safety Reports (ICSRs) in line with regulatory requirements and timelines.
• Support of EudraVigilance reporting and safety database activities.
• Medical literature monitoring and safety information assessment.
• Preparation and review of periodic and aggregate safety reports, including PSURs/PBRERs.
• Preparation, maintenance and review of Risk Management Plans (RMPs).
• Contribution to Pharmacovigilance System Master Files (PSMFs) and Safety Data Exchange Agreements (SDEAs).
• Pharmacovigilance compliance monitoring, deviation handling and CAPA activities.
• Participation in audits and regulatory inspection readiness.
• Monitoring of applicable pharmacovigilance legislation and regulations.
• Collaboration with clients, partners and internal cross‑functional teams.

Required profile

• University degree in Pharmacy, Medicine, Biology, Life Sciences or a related scientific discipline.
• Minimum 3‑5 years of professional experience in Pharmacovigilance, preferably in the pharmaceutical industry or a CRO.
• Good knowledge of EU pharmacovigilance legislation, GVP and relevant ICH guidelines.
• Hands‑on experience in ICSR management and familiarity with EudraVigilance and safety databases.
• Experience with aggregate safety reports, RMPs and PSMFs; prior role as an EU Qualified Person for Pharmacovigilance (QPPV) is an asset.
• Excellent written and verbal communication skills in English and Greek.
• Strong organisational skills, attention to detail and ability to manage multiple priorities and deadlines.
• Ability to work effectively both independently and as part of a team.

Required skills

• ICSR management
• EudraVigilance system
• Safety databases
• Aggregate safety report preparation
• Risk Management Plans (RMPs)
• Pharmacovigilance System Master Files (PSMFs)

What we offer

• Competitive salary
• Training and development opportunities