Job Description

Overview:

Job Purpose

To ensure effective coordination and regulatory compliance of all pharmacovigilance activities across the UK and Ireland. The role involves managing safety cases from both spontaneous and solicited sources, overseeing safety governance for Patient Support Programmes, and supporting the maintenance of robust PV systems and processes in line with local and global regulatory requirements.
Responsibilities:

Main Accountabilities

To contribute in maintaining a local pharmacovigilance system in conjunction with Global Vigilance and ensuring that all delegated National Safety Officer (NSO) responsibilities for UK and Ireland are met as per global procedures. Overseeing and performing comprehensive review of serious and non-serious adverse event (AE) reports from various sources (spontaneous, PSP, Health Authority, Ulysses, Medical information, media groups). Ensuring accurate data entry, medical coding (MedDRA, WHO Drug), and causality assessment. Performing quality control (QC) checks on ICSRs processed by other PV colleagues to ensure accuracy, completeness, and compliance with SOPs and regulations. Ensuring timely and compliant submission of ICSRs to regulatory authorities (e.g MHRA) Managing follow-up activities to obtain complete and accurate information for ICSRs. Performing reconciliation of cases with internal functions (e.g. Medical Information) and external partners (e.g. PSP programs). To support in updating global PV System Update Routine (ePUR) to ensure local and global oversight on quality system and PV processes (including training, audit, outsourcing of PV activities). Having a good understanding of the Pharmacovigilance System Master File (PSMF) for UK-authorised products, and contributing to its accuracy, completeness, and inspection-readiness.To ensure the necessary quality, including the correctness and completeness of pharmacovigilance data is submitted to UK competent authorities and to Global Vigilance in accordance with the legal requirements and as per global procedures.Drafting and updating Pharmacovigilance Standard Operating Procedures (SOPs)/ Work Instructions (WIs) to reflect current regulations and best practices. To ensure the necessary quality, including the correctness and completeness of pharmacovigilance data is submitted to UK competent authorities and to Global Vigilance in accordance with the legal requirements and as per global procedures. Drafting and updating Pharmacovigilance Standard Operating Procedures (SOPs)/ Work Instructions (WIs) to reflect current regulations and best practice Performing root cause analysis and developing effective Corrective and Preventive Actions (CAPAs). Actively contributing to preparations for internal audits and external regulatory inspections (e.g., MHRA, EMA).

Qualifications:

Experience & Qualifications

Should possess a scientific degree or equivalent in Life Sciences, Pharmacy, Medicine, or a related discipline. 2-3 years of hands-on experience in pharmacovigilance/drug safety. Solid understanding of GVP guidelines, and UK/EU pharmacovigilance regulations. Experience in case processing (spontaneous and solicited reports), MedDRA coding, and safety database systems. Exposure to PV activities such as signal detection, risk management, and safety reporting desirable. Strong analytical skills with attention to detail and accuracy. Excellent written and verbal communication skills in English. Ability to work independently as well as collaboratively in a cross-functional, global environment. * Good organisational and time-management skills to handle multiple priorities