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• Bachelors, or above, degree in Biomedical or Health Care related speciality.
• Advanced evaluation skills and analytical thinking for scientific literature review, data gathering, data synthesis, analysis and interpretation.
• Strong medical/scientific writing skills.
• Sound computing skills.
• In depth knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
• In depth understanding and experience of causality assessment, evaluation of safety signals and of proactive risk management strategies, including management of labelling changes, physician and patient education and monitoring of safety issues.
• Sound knowledge of therapy areas of assigned products.
• Knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology and associated methodologies) pertinent to assessing drug utilization and safety at the population level.
• Sound knowledge of medical and drug terminology.
• Clear understanding of drug development process and the drug approval process in major countries
GlaxoSmithKline (GSK) is one of the world’s leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.
We are currently recruiting a Pharmacovigilance Manager to be based in Stockley Park, London, UK.
The successful candidate will be involved with a diverse range of activities including:
• Conducts, or leads with guidance, pharmacovigilance and risk management planning for designated products, including preparation of global Benefit-Risk Management Plans, in partnership with the product physician.
• Contributes to regulatory benefit-risk assessments and prepares the regional Risk Management Plans for designated products.
• In partnership with the product physician, provides the clinical safety input into Clinical Development planning activities.
• Represents GCSP on cross-functional Clinical Matrix Teams and/or Project Teams for developmental compounds. Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
• Runs routine signal detection process (including On-Line Signal Management Tool, literature review and, in partnership with product physician, tools for individual case awareness) for all products in area or responsibility.
• Presents on labelling recommendations for complex issues to GSK Global Labelling Committee or Global Safety Board, in partnership with product physician.
• Produces regulatory supporting documentation for labelling updates.
• Authors periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines. Co-ordinates the compilation of large PSURs requiring a GCSP team approach and provides high-level summaries on major issues.
• Supports the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market.
Closing date for applications: Friday 20th October 2017.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
When applying for this role, please use the 'cover letter' of the on-line application to 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 and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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