Reference: PW 6690
Closing Date: 11 Nov 16
Salary (£): Competitive
Leading global pharmaceutical company
This company supports involvement in the Diploma in Pharmaceutical Medicine and Pharmaceutical Medicine Specialty Training (PMST) with the Faculty of Pharmaceutical Medicine
There is scope for the Senior Safety Evaluation Physician to attend appropriate scientific and medical courses (as appropriate for maintaining basic medical knowledge, for advancing skills as appropriate to those drugs for which he/she is responsible, for maintaining and expanding skills associated with safety surveillance and as required under terms of continuing medical education.
· As assigned by the Global Safety Board Chair, to act as General Safety Officer (GSO) to proactively manage the global safety aspects for a specific product, or group of products as defined in company policies and SOPs.
· To be a member of the Global Safety Board – the body which manages pharmacovigilance globally for the company
· As General Safety Officer (GSO) for an assigned group of products, support the Head of Safety Evaluation and the QPPV in the collection, assessment, evaluation, distribution and reporting of individual and cumulative safety reports.
· To lead the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified products.
· Be responsible for leading safety evaluation, including signal detection and benefit-risk analysis
· Provide safety expertise to the international project team for assigned products including the production and maintenance of Risk Management Plans and Risk Minimization Activities.
· Leading the production and amendment of safety information, including product labelling for specified products.
· To lead the safety related aspects of the design and running of clinical studies, including involvement in the protocol production, investigators brochure production, support to the study team, monitoring of safety signals and involvement in the production of the clinical study report.
· To establish and maintain a high level of familiarity with the local, European, and international pharmacovigilance regulations and guidance relating to drug safety and pharmacovigilance and act as a point of reference for others.
· To contribute as a senior and respected member of the drug safety community in the day-to-day functioning of an effective regional and global drug safety network
QUALIFICATIONS / EXPERIENCE REQUIRED:
Qualifications and Experience Required.
· The Senior Safety Evaluation Physician will be expected to hold a UK GMC-approved or other similar country medical registration and have demonstrated experience in post-registration clinical medicine.
· The Senior Safety Evaluation Physician will have acquired previous experience in Product Safety during which a consistent record of strong contribution was demonstrated, in addition to success in tackling new challenges and responsibilities.
Skills and Aptitude Required
· Possess a strong sense of responsibility and have a good track record of working independently and meeting strict deadlines.
· Flexibility, adaptability and pro-activity are key requirements for the position.
· Excellent communications skills.
· Ability to work consistently conforming to procedures and requirements yet possess a degree of flexibility in order to meet the various demands and priorities.
· Team player able to provide mentoring and support to less experienced physicians in the Product Safety department in a professional and empathetic manner.
· Able to form strong cross-functional relationships.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to email@example.com quoting reference PW 6685.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk
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