Senior Medical Director, PVG

Proclinical is currently seeking a Senior Medical Director, PVG for a fast-growing biopharmaceutical company based in Cambridge, UK. The Medical Director, Pharmacovigilance ("PV") will be an experienced pharmaceutical physician with strong clinical and pharmaco-epidemiologic experience in pre and post marketing settings. S/he will have the demonstrated ability to analyse safety data, identify, detect and investigate safety signals, evaluate and proactively manage risk, and provide medical safety review for investigational compounds and marketed products. S/he will provide medical input into activities associated with serious adverse events from clinical trials and post-marketing adverse events and will co-author aggregate safety documents, including NDA/MAA submission safety documents, periodic reports and responses to regulatory questions. All activities will be done in close collaboration with PV Operations, Clinical Science, Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Affairs/Medical Information and external partners using best PV practices. The Medical Director will also represent company Drug Safety at internal and external meetings and must be versed in policies and procedures regarding PV and product quality that align with prevailing FDA, EU, and other locally applicable regulations.

Job Responsibilities:

• Serve as the PV medical lead and primary point of contact for one of more programs, providing PV supporting for compounds in clinical development and/or marketed products as appropriate.
• Accurately identify, develop, analyse and summarize safety issues that require further evaluation utilizing data from the safety and clinical databases as necessary.
• Author or contribute to safety sections of clinical investigator brochures, protocols, CSRs, core safety information, labels and regulatory reports (e.g. PSUR, DSUR, PADER, Annual IND report; 6-monthly line-listings) with focus on providing overview for the medical analysis and safety sections.
• Author or contribute to Safety sections of NDA/MAAs and other regulatory submissions (e.g., integrated summary of safety, and/or summary of clinical safety, PSMF, RMP, etc.).
• Lead signal detection and risk management activities for designated product(s).
• Implement proactive safety analysis strategies to further define the safety profile.
• Lead aggregate safety data review activities and coordinate safety surveillance activities.

Skills & Requirements:

• M.D. degree or equivalent with a minimum of five (5) years' experience in PV organizations in the pharmaceutical/biotechnology industry is required. Oncology experience will be a significant advantage
• Experience in clinical and post-marketing safety, and pharmaco-epidemiology.
• Knowledge of current pre-and post-marketing, US and international safety regulations.
• Advanced ability to analyse and interpret clinical data.
• Experience of unsupervised medical review of serious adverse event cases
• Experience and training in MedDRA coding, and coding review
• Strong organizational skills with ability to manage multiple projects.
• Thorough knowledge and experience in all aspects of safety reporting for clinical trials and marketed products.
• In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements pertaining to drug safety and risk management including ICH, CFR 21, FDAAA, and EU GVP module and able to influence decisions at all levels relating to patient safety.
• Travel as required (expected to be up to 10%)

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.