SRG Clinical are working with a company to recruit for a permanent Senior Pharmacovigilance Associate. Primary duties include: ' Following induction to the company and training, the Senior Pharmacovigilance Associate would be responsible for: ' 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. Interested applicants should have a well established working knowledge of Pharmacovigilance in a Pharmaceutical or Contract Research Organisation environment, in particular current Post-marketing case report handling.

 

A comprehensive understanding of EU Pharmacovigilance regulatory guidelines and legislation is required. You will also be 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. If you are interested or would like a confidential discussion, please contact Priya Mukherjee on 0207 562 1791 or email priya@srgclinical.com The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency. SRG winners of the 2008 Recruiter Awards for Excellence: Best Candidate Care and Best Health Care/Medical Recruitment Firm.