Pharmacovigilance Officer

About the role

Drug safety at BioLink covers eleven active trial protocols plus post-marketing surveillance for the products we hold licences on. Volume is steady rather than crushing: around 90 individual case safety reports a month, with the usual spikes when a study reaches recruitment peak.

We are hiring a Pharmacovigilance Officer at associate level and we would rather train the right person than land a fully formed one. You will get four weeks of structured onboarding on MedDRA coding, seriousness and expectedness assessment, and our safety database, and a named mentor who reviews every case you process for the first ninety days.

You will sit with the safety team of five under Dr Anita Sengupta, our Head of Drug Safety, and interact daily with clinical operations, sites and the sponsor safety desks. The people who have done well in this seat treated regulatory timelines as immovable and asked awkward questions early.

What you'll do

• Receive, triage and process individual case safety reports within regulatory reporting clocks
• Code adverse events and medical history to MedDRA and assess seriousness, causality and expectedness with medical review
• Draft and issue follow-up queries to investigator sites, and chase them to closure
• Prepare expedited reports for submission and maintain the submission tracking log
• Support aggregate reporting — DSURs, PSURs and line listings — including data reconciliation with clinical data management
• Contribute to signal detection meetings and keep the safety database reconciled with the clinical database before each lock

What we're looking for

• 2+ years in pharmacovigilance, drug safety, clinical research or hospital pharmacy
• Life sciences, pharmacy, nursing or medical degree
• Understanding of ICH-E2A/E2D concepts and the reporting timelines that follow from them
• Meticulous written English; most case narratives are written and reviewed in English
• Comfortable working to a clock every single day without losing accuracy

Nice to have

• Hands-on use of Argus Safety, ArisGlobal or a comparable safety database
• MedDRA coding certification
• Exposure to both trial and post-marketing safety work

What you get

• 13th month salary and annual performance review
• Four-week structured onboarding with a named mentor for your first quarter
• Sponsored MedDRA and pharmacovigilance certification
• Hybrid working, two days from home once you are past probation
• Medical and dental cover; visa sponsorship available