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• Medical degree.
• Experience of working within a Pharmaceutical, Biotechnology or Clinical Research services company.
• Pharmacovigilance, Medical Affairs, Clinical Development or Clinical Research experience.
• Experience of Signal Detection is preferred.
GSK research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. Since 2009 we’ve had more new medicines approved than any other healthcare company, including treatments within Respiratory, HIV, Cancer and Immuno-Inflammation therapy areas. We also have many potential new medicines and vaccines in development.
Our extensive product pipeline strength and our overarching vision to focus on the patient continue to emphasize the great need for exceptional physician talent across our organization within the realm of drug discovery, drug development and medical affairs on both global and national levels.
An exciting new role has become available for a Drug Safety/Pharmacovigilance Physician within our Global HIV Safety Evaluation and Risk Management group based at our offices in Stockley Park. The role will involve carrying out signal detection, safety evaluation and risk management activities related to a specific portfolio of established HIV medications on a global basis. The role will initially focus on post marketing activities. Once established within the role the Safety Physician could take on responsibility for products in Clinical Development.
This role is unique as it is strongly aligned to ViiV Healthcare. The individual taking up this role will have the advantage of working with a smaller and more agile organisation such as ViiV whilst having the infrastructure and support that would expected of a leading global pharma company such as GSK.
For this particular role we are open to considering Physicians who may already be working within the Pharmaceutical industry in Medical Affairs, Clinical Development or Clinical Research who may want to transition into a Pharmacovigilance focused role.
The role: Safety Physician, Safety Evaluation and Risk Management Medical Director, HIV
Working in partnership with the product scientist you will support the safety review of assigned products by conducting safety evaluation and risk management planning activities.
Your activities may include:
• Lead or support the proactive monitoring and evaluation of all aspects of the safety profile of designated products (ViiV marketed products) and ensure that optimal decisions are made at all stages of the product lifecycle.
• Lead or support the discussion and management of safety issues through matrix teams across the global organisation and present your findings to high level clinical teams and/or GSK governance bodies.
• Ensuring that safety documents (e.g. periodic reports, signal evaluations, labelling documents, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirements.
• Providing medical review and sign-off for regulatory documents including PBRERs, RMPs, and DSURs.
• Developing safety plans and strategy for safety data collection, data analysis and interpretation.
• Leading discussions relating to the management of safety issues through matrix teams, across the global organisation.
• Presenting findings to high level clinical teams or governance bodies.
The individual joining GSK in this role can progress into a different role within 2-3 years. This could be progression into a more senior safety role or a move into another area such as Medical Affairs or Clinical Development.
The closing date for applications is Tuesday 24th October.
Please apply using the online system
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities.
If requiring an adjustment for a disability once selected for an interview, you may contact firstname.lastname@example.org
**GSK Employee’s:- If you are at risk of being displaced please indicate this on your applications in the cover letter**
You may apply for this position online by selecting the Apply now button.
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