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Hobson Prior are currently working with a Clinical Trial Monitoring Service who are seeking a Pharmacovigilance Associate to join them on a permanent basis in Crawley. As the Pharmacovigilance Associate you will be responsible for managing the day-to-day operations of the Pharmacovigilance department.
- Prepares and implement Safety Management Plans specific for the study protocol and Sponsor requirements.
- Manages the receipt and processing of SAE reports according to the Safety Management Plan, or equivalent document.
- Reviews SAE reports and any supporting documents for accuracy and completeness.
- Enters safety data into the organisation's Safety Database.
- Writes patient narratives.
- Codes Serious Adverse Events accurately using MedDRA.
- Makes the preliminary assessment of expectedness against appropriate Reference Safety Information.
- Identifies significant missing information from reports and ensure its collection.
- Ensures case receives appropriate medical review.
- Prepares follow-up correspondence.
- Ensures cases that require expedited reporting to regulatory agencies are processed within the timelines identified in the SMP.
- Provides independent QC of SAE reports for other members of the group.
- ARGUS experience is essential.
- 1-2 years Drug Safety experience.
- Case processing experience.
- SUSAR experience (advantage).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.