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Senior PV Officer

2 months ago

Reading, Reading, United Kingdom Cpl Full time

Senior Pharmacovigilance Officer

Location: Reading – 50% Hybrid based

Salary: up to £60,000 per annum plus bonus and benefits

Cpl Life Sciences have partnered with a global, innovative healthcare company to bring on board a Senior PV Officer to join their team and work in a varied position across different portfolios and therapy areas,

Requirements for the role are:


• Life Science degree Graduate or qualified health professional


• Practical experience in Drug Safety/Pharmacovigilance


• Experience in leading projects


• Working knowledge of risk management, signal detection, PSURs, safety assessments


• Experience in Post Marketing


• Strong communication and cross collaboration skills


•

Key Responsibilities are but not limited to:


• Monitor and document safety data to identify tends and potential signals/issues


• Broad remit across risk management, signal detection and Periodic reporting


• Contribute to the preparation of PV related documents [PSUR, RMP, additional Risk Minimisation Materials, Safety assessments]


• Ensure prompt response to requests for further information or queries received from the Global PSPV team or the MHRA


• Maintain PV procedures in line with current regulations and company policies


• Manage compliance and quality checks, partner compliance and outsourced Service Provider compliance


• Work closely with the Management team to ensure that PV procedures remain consistent with relevant developments in National, European and International regulations, legislation and guidelines


• Participate in audits and inspections and contribute to the development of corrective and preventative actions, as necessary

If this roles sounds of interest please apply direct, or send your CV to

.