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Skills Alliance Limited
,
London, Greater London
Safety Evaluation and Risk Manager - Pharmacovigilance Manager
Overview
A leading global Pharmaceutical company are currently recruiting for a Safety Evaluation and Risk Management – Pharmacovigilance manager based in London. The role sits in the pharma safety group which supports all aspects of the safety profile of the company’s medicine portfolio both in development and post marketing. In this role you will join a team engaged in early post marketing activities for one of the recently launched respiratory medicines. The pace is very dynamic with some opportunity to work flexibly across different projects. Key Responsibilities: Provide high level scientific expertise in the safety evaluation and risk management of GSK medicines either in clinical development and/or the post-marketing. Ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives Support the disease area or product area safety strategy at internal company cross functional meetings and may represent the company externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners Participate in pharmacovigilance and risk management planning in the clinical matrix. Plan and prioritize activities for designated products Lead safety input into regulatory benefit-risk assessments and the preparation of Risk Management Plans Deliver the clinical safety input into clinical development planning activities May represent clinical safety on cross functional Clinical Matrix Teams and/or Project Teams. Contribute to cross-functional ad hoc teams to address urgent and important product safety issues Review and provide technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. May lead or participate in discussion at Global Safety Board for safety related findings. Escalate safety signals appropriately as identified through the Safety Review Process Additional responsibilities in Signal Detection, Evaluation, Labelling and submissions Requirements: Prior experience in pharmacovigilance including aggregate reports and risk management activities. Strong evaluation skills and analytical thinking Medical writing skills Sound knowledge of relevant pharmacovigilance regulations and methodologies applicable to safety evaluation and risk management activities Track record of quality decision making, and problem resolution based on assessment of all relevant supporting and conflicting information/factors Experience in managing complex tasks in a matrix team setting. Degree in Biomedical or Health Care related specialty This role is based in London and comes with a competitive base salary benefits package. Skills Alliance are the preferred supplier for this role. For more information or to apply please contact Ibraheem Idrissi on 0207 220 6204 or quick APPLY NOW This job was originally posted as www.totaljobs.com/job/89911299