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PV Physician, BaselRef: TJBSWIID01

Salary:€150000 - €185000 per annum

Added:13 Feb 2020

Region: Europe

Sector: Pharmaceutical

Sub Sector: Drug Safety

An excellent opportunity has arisen for an experienced PV Physician to join a European biotech hub, specialising in the discovery and development of small molecules. Job Responsibilities: -Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the product's life cycle -Lead the cross-functional Safety Management Team (SMT) for assigned projects/products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management -Provide drug safety expertise in all phases of drug development -Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information -Responsible for the preparation of aggregated periodic safety reports: DSUR, PSUR/PBRER, Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contribute to other key regulatory key safety documents -Review, contribute and provide medical and safety expertise for study synopsis, protocol, Core Informed Consent (CIC), Briefing Book (BB), Clinical Development Plan (CDP), Clinical Study Report (CSR), Investigational Medicinal Product Dossier (IMPD), Statistical Analysis Plan (SAP) and Paediatric Investigation Plan (PIP) as required -Responsible for responses on safety inquiries from regulatory authorities or health care professionals Candidate's Requirements: -Doctor of Medicine degree with at least 7-years' experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry -Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information -Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance -Full understanding of the clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents -Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements -Previous experience with regulatory filing and contribution to key safety documents -Good experience and knowledge with safety signal identification methodology and risk minimization measures -Excellent medical writing, presentation and communication skills For further details about this role, or other vacancies within PV & Drug Safety, please contact Tim Barratt at Key People on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

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