Senior Pharmacovigilance Associate - UK - Cambridge

Pharmaceutical Company is now looking to recruit a Senior Pharmacovigilance Associate. You will be reporting into the Pharmacovigilance Manager and be responsible for the following:

* Entering and review of SAE/AE reports (including narrative writing) from clinical trial and post marketing sources onto our global safety database (ARISg), in accordance with company SOPs and regulatory requirements

* MedDRA coding, including study coding reviews.

* Performing end of study reconciliation with the clinical database

* Supporting global regulatory submissions including E2B

* Literature reviews

* Responding as necessary to Medical Information safety queries

* Maintaining Pharmacovigilance systems including the global safety database.

* Contributing to the ongoing enhancement of Pharmacovigilance processes and SOPs, including internal and external staff training.

* Support for the creation and review of PSURs, ASRs, CSRs, and regulatory dossiers.

Experience:

You must have had experience of a similar environment and in particular, Post-marketing case report handling. A high level of understanding in EU Pharmacovigilance regulatory guidelines and legislation is required. Competent with medical terminology and possess good IT skills, with previous use of safety databases (preferably ARISg web based). A high standard of report writing and impeccable attention to detail is essential, as well as excellent communication abilities. Medical writing skills would be advantageous. This is an excellent opportunity for a candidate seeking to broaden their safety knowledge in both a clinical trial and spontaneous setting and to be part of a progressive department.

If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.

SEC Pharma People are acting as an Agency and or Employment Business
For a confidential consultation call Manpreet Mangat on 0044 (0) 207 255 6600 or email your CV to
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SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business