Pharmacovigilance Scientist, Open to flexibility

Location
Stockley Park, London
Salary
£Competitive
Posted
10 Oct 2017
Closes
20 Nov 2017
Ref
WD141098
Contract Type
Permanent

Pharmacovigilance Scientist, Open to flexibility

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 Scientist 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.

Thank you for your interest in this opportunity.

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