Assistant II – Clinical Safety & Pharmacovigilance

About the role

We are looking for an Assistant II to support our Clinical Safety and Pharmacovigilance (PSS) operations. The role involves handling the full adverse‑event lifecycle, from data collection in clinical trials and post‑marketing settings to the preparation and submission of expedited safety reports.

Key responsibilities

• Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) and ensure timely submission to clients, regulatory authorities and ethics committees.
• Maintain and update adverse‑event tracking systems and project documentation.
• Log incoming adverse event (AE) and serious adverse event (SAE) reports, enter safety data, and draft patient narratives.
• Code events using MedDRA terminology and perform listedness assessments for marketed products.
• Generate queries for missing or discrepant information and support peer quality reviews.
• Assist in database reconciliation, file archiving and preparation of safety study files.
• Coordinate internal and external meetings and provide training to junior assistants.

Required profile

• Attention to detail and ability to work within defined timelines.
• Understanding of health‑safety regulations such as the Health and Safety at Work Act, COSHH and relevant EU directives.
• Experience in a regulated environment, preferably within pharmacovigilance or clinical safety.

Required skills

• MedDRA coding
• Use of adverse‑event tracking systems
• Safety data entry and narrative writing
• Regulatory submission processes
• Quality Management System (QMS) procedures and SOP compliance