Roles & Responsibilities:
• Perform local safety case receipt, processing, data entry, QC tracking, and ICSR follow-up in line with agreed timelines.
• Manage generic and client-specific safety email inboxes.
• Register, triage, assign, and coordinate processing of vigilance cases.
• Perform follow-up with local reporters for missing or additional information.
• Respond to queries from clients and reporters.
• Conduct periodic reconciliations to ensure complete and compliant handling of safety reports.
• Support local pharmacovigilance activities as required.
• Participate in audits, inspections, and implementation of corrective action plans.
Qualification:
• Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, or a science-related field (or equivalent experience).
Experience:
• 2+ years of experience in Pharmacovigilance within a service provider environment.
• Hands-on experience in safety case data entry and QC.
• Experience working to strict timelines and managing client communications.
• Knowledge of UK and EU PV regulations.
• Strong pharmaceutical background with understanding of GVP, GCP, FDA, and drug safety regulations.
• In-depth knowledge of PV principles, adverse event reporting, and causality assessment.
Skills:
• Excellent organizational and interpersonal skills.
• Strong team-working capability.
• Effective time management and prioritization skills.
• High level of accountability and autonomy.
• Process-oriented with strong attention to detail.
• Clear written and verbal communication skills to explain complex concepts.
• Flexible and adaptable in a dynamic work environment.
• Ability to work under pressure and meet deadlines.
• Safety database experience preferred.
About the Organisation:
ProductLife Group is a global life sciences consulting and services company delivering end-to-end solutions across pharmacovigilance, regulatory affairs, quality, and compliance, supporting pharmaceutical, biotechnology, and medical device companies worldwide throughout the full product lifecycle.
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