Pharmacovigilance Physician to join a pharmacovigilance team based in High Wycombe, UK.
Working as a medic in a pharmacovigilance team, you will be supporting anti-infective products as well as oncology and pain. You will be a GMC registered medic, available for a full time interim contract of 37 hours per week based in the South East of England.
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process. The Pharmacovigilance Physician (PVP) has primary responsibility for determining the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.
This medical expertise will be reflected in activities such as 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.
For a full job description or to discuss this role further please contact Ben Traies at email@example.com or call on 01438 870021.
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