Clinical Safety Scientist

4 weeks ago

London, United Kingdom Cypartners Full time

CY Partners are seeking a talented and dedicated Clinical Safety Scientist to join a global pharmaceutical companiesdynamic team in the UK. They areseeking a Pharmacovigilance Scientist in the Safety Evaluation and Risk Management team within their Global Safety Department, aligned with their HIV product portfolio.

As a Scientist, you will also play a strategic role, driving discussions and improvements in safety management. You’ll present findings to senior stakeholders and governance bodies and must therefore be comfortable engaging with colleagues at all levels of the organisation. This position offers the successful candidate the chance to develop your expertise, and making a significant personal impact on the safety of HIV products. You’ll, you’ll work with a highly skilled and supportive team – a group where individuals help one another both in their progression and growth, and in their regular activities.

It is an initial 12 Month Contract role

Key Responsibilities

  • Assisting with the monitoring and evaluation of safety profiles for allocated products to ensure that optimal decisions are made at all stages of the product lifecycle
  • Conducting routine pharmacovigilance activities (knowledge of the Common Wealth Vigilance Workbench would be advantageous), signal detection/evaluation and leading authoring of key regulatory documents (e.g. DSURs, EU RMPs and PBRERs)
  • Ensuring that all safety documentation is accurate and available to meet global compliance and regulatory requirements
  • Driving discussions and the management of safety issues within the wider safety team
  • Leading presentation of safety-related findings to senior stakeholders (including Vice President and Senior Leadership Teams) and to ViiV’s governance bodies

Role Requirements

  • Bachelors, or above, degree in Biomedical or Health Care related speciality
  • Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
  • Competent medical/scientific writing skills
  • Sound computing skills Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
  • Knowledge and experience of the principles of causality assessment and the evaluation of safety signals
  • Basic understanding of the HIV therapy area would be an advantage
  • Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology)
  • Basic knowledge of medical and drug terminology anddrug approval process in major countries

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