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Clovis Oncology
,
London, Greater London
Associate Medical Director - Medical Reviewer
Overview
Job Description
Job Summary The Associate Medical Director, Medical Reviewer is responsible for conducting medical review of individual case safety reports and safety data, as well as contribution to aggregate safety reports and narratives for regulatory requirements/commitments for US, EU, and other regulatory agencies for Clovis products. Responsibilities * Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving Clovis products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting * Assist in follow-up of important ICSRs to ensure relevant information is sought * Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Reports, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report) * Contribute to preparation of safety narratives * Contribute to preparation of responses to health authority requests as required Essential Functions * Provides appropriate medical interpretation and consistency to adverse event case assessment * Provides pharmacovigilance and drug safety support for internal and external customers * Maintains knowledge of global regulatory authority regulations (especially FDA and EMA) and apply appropriately to all activities * Contributes to the training, leadership, and continuing education for all departmental staff * Provides medical contribution and performs medical review of aggregate reports * Provides medical input into signal management activities (detection, validation, assessment) for assigned products * Performs aggregate safety data review on an ad hoc basis in order to support safety evaluations * Participates in departmental activities to ensure internal audit and regulatory inspection readiness Experience and Education Required Skills: * M.D. degree required * Excellent medical knowledge with the ability to interpret, synthesize and communicate complex medical/pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs * Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally * Excellent oral and written communication skills Preferred Skills: * Experience in pharmaceutical industry * Experience reviewing cumulative safety data * Experience with pre- and post-marketing ICSR processing and aggregate safety reporting. * Knowledge of MedDRA terminology and its application * Knowledge of individual adverse event case report processing, triage and medical review * Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice * Experience with safety databases (Argus preferred) and safety coding dictionaries (MedDRA, WHODRUG) Working Conditions * Up to 10% travel is possible * May have to support with holiday coverage to meet department deliverables, regulatory timeline and remain compliant with Competent Authority deadlines