Medical Director SERM
GSK
Brentford, United Kingdom
1d ago

Are you a safety / pharmacovigilance physician with in-depth and hands-on experience? Do you want to work on the development and introduction of a new medicine that will have global impact?

Do you want to work with high-profile partners like the World Health Organisation, Bill and Melinda Gates Foundation and the US Centre for Disease Control and Prevention?

If you've answered yes to all 3 questions, don't miss out on this fantastic opportunity!

ROLE SUMMARY

You will provide high level medical expertise in the safety evaluation and risk management of a new antimalarial medicine in clinical development and / or the post-marketing setting.

You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives

We expect you to have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes.

We also expect you to be able to influence at all levels of the organisation using your experience, confidence and credibility.

RESPONSIBILITIES

  • Safety Governance and Risk Management activities
  • Signal Detection, Evaluation and Labelling
  • Regulatory Reports and Submission
  • Presents the disease area or product area safety strategy at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
  • Accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs)
  • Other SERM Activities including driving the review or production of the SERM component of Safety Data Exchange Agreements;
  • participating in due diligence activities; providing support to GSK Legal for product liability litigation; providing input to, or participating in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC), etc.

    Why you?

    Basic Qualifications :

    We are looking for professionals with these required skills to achieve our goals :

  • Medical Degree, ideally GMC qualified
  • Expert evaluation skills and analytical thinking
  • Outstanding medical writing skills
  • Sound computing skills
  • Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
  • Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
  • Sound knowledge of the therapeutic area of assigned GSK products
  • Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
  • In depth knowledge of medical and drug terminology and a sound foundation in pharmacology. Good medical judgement and ability to make medical decisions
  • Clear understanding of clinical development process
  • Clear understanding of drug approval process in major countries
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