Pharmacovigilance Specialist

About the role

The Pharmacovigilance Specialist collaborates with the PV production team to analyse safety data and ensure patient safety for client products. The role provides day‑to‑day coordination and administrative support for literature monitoring projects, helping the Production team meet client timelines and deliverables.

Key responsibilities

• Analyse adverse events, process case data and prepare safety reports for health‑authority submission.
• Maintain data integrity and audit compliance by following Good Documentation Practice (GDP) standards.
• Monitor project timelines, communicate progress proactively with Team Leads and Project Managers, and ensure high‑quality outputs.
• Oversee administrative aspects of non‑linguistic PV projects, including file transfers, internal checks and client deliverables.
• Address stakeholder safety‑related complaints in real time, discuss mitigation strategies with Project Managers and drive solutions.
• Collaborate with senior team members to support smooth and timely client deliveries.

Required profile

• Minimum Bachelor degree or equivalent, with at least one year of pharmacovigilance experience.
• Medical background preferred (Doctor of Pharmacy, Life Sciences degree, or related).
• Experience working in cross‑functional, collaborative teams.

Required skills

• Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding.
• Familiarity with Good Clinical Practice (GCP), Good Documentation Practice (GDP) and ICH guidelines.
• Proficiency in Microsoft Word, PowerPoint, Excel, Outlook and EndNote.
• Ability to search scientific databases such as PubMed and Embase.