Our client, a global pharmaceutical company is looking for a Pharmacovigilance Physician to join their team based in the South East of England.
The main responsibilities of this Pharmacovigilance Physician role will include:
- Determining the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile: spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.
- Determining key events of interest, emerging safety issues identified from important individual case safety reports, assigning appropriate dictionary terms during coding and performing causality assessments for the purpose of determining international regulatory reporting requirements.
- Medical evaluation of adverse event reports, including but not limited to all serious and expedited reports and all pregnancy reports.
- Preparation of IND letters to investigators (SUA summaries).
- Provide medical guidance and opinions to drug safety associates, other physicians and scientific staff in the evaluation and follow-up of individual case safety reports. Provide medical input for ad-hoc queries as requested.
- Participate in signal detection efforts, e.g. strategy meetings for PSURs and periodic reports and structured surveillance programs and other medical/scientific meetings.
- Review aggregate reports such US Periodic Reviews and non-serious line listings of events on a weekly basis to assess correct seriousness classification.
- The primary decision making responsibility of this Pharmacovigilance Physician role centres on the assessing the medical significance of the individual case safety report.
Requirements & Experience:
The successful candidate will be a GMC registered medic supporting anti-infective products as well as oncology and pain. You will provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process
- Fully GMC registered Physician,
- Broad clinical experience.
- Sound knowledge of general medicine and clinical practice as evidenced by subspecialty medical training and/or medical practice experience is required.
- Good communication skills, both written and verbal are required, as well as the ability to work in a team-orientated, matrix environment.
For more information, or to apply for this Pharmacovigilance Physician job, please contact Ben Traies at CK Clinical on +44 (0) 1438 743047 or Btraies@ckclinical.co.uk. Quote Reference number: 20845.