Associate II – Clinical Safety & Pharmacovigilance

About the role

The Associate II PSS provides essential support for clinical safety and pharmacovigilance operations, handling adverse event data from clinical trials and post‑marketing sources. The role ensures timely, accurate processing and submission of expedited safety reports to clients and regulatory authorities.

Key responsibilities

• Receive, enter, and track all adverse event reports in designated safety databases.
• Review reports for completeness, accuracy, and suitability for expedited reporting.
• Write patient narratives and code events using MedDRA terminology.
• Identify missing clinically significant information and coordinate follow‑up with medical staff.
• Ensure cases receive appropriate medical review and are submitted within regulatory timelines.
• Prepare and submit expedited Serious Adverse Event (SAE) reports, Periodic Safety Reports (PSRs), and other required documentation to clients, ethics committees, investigators, and regulatory bodies.
• Assist with database reconciliation in collaboration with data management teams.
• Maintain adverse event tracking systems and project documentation.
• Perform quality or peer reviews of processed safety reports.

Required profile

• Strong attention to detail and ability to work under strict deadlines.
• Excellent written communication for preparing narratives and correspondence.
• Ability to collaborate with medical, regulatory, and project teams.
• Understanding of health‑and‑safety regulations such as the Health and Safety at Work Act and COSHH.

Required skills

• Proficiency in MedDRA coding and terminology.