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Job Title for the Vacancy *
Pharmacovigilance (PV) Manager
Location:
University of Birmingham
Type:
Full Time
Basis of Employment:
Permanent
Closing Date:
21 April 2025
Description:
Role Summary
An integral part of clinical trials involves the collection, analysis and reporting of safety information and adverse events including adverse reactions and the identification of any event that is serious and unexpected. It is essential that cases are assessed and reported appropriately in compliance with applicable legislation.
The trials portfolio within CRCTU is broad and includes Clinical Trials of Investigational Medicinal Products (CTIMPs), non-CTIMP trials, device trials and trials of Advanced Therapy Investigational Medicinal Products (ATIMP) for which safety reporting requirements may vary.
The post holder will lead on pharmacovigilance (PV) and safety reporting within the CRCTU working closely with the CRCTU Director of Operations to develop and maintain appropriate systems and to meet reporting requirements. Activities will include advising on (and where applicable assessing) Serious Adverse Events (SAEs), preparation of development safety update reports, and regulatory reporting to the Medicines for Health Regulatory Agency (MHRA) Individual Case Study Report (ICSR) and the European Medicines Agency (EMA) EudraVigilance systems. The post holder will also identify areas of ineffective working for PV and safety reporting activities and develop approaches to improve operational effectiveness.
How to apply:
Informal enquiries to Dr Sarah Bowden, email: s.j.bowden@bham.ac.uk
Link for Further Information/Apply: Apply Here
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