Drug Safety Administrator

Our Client is looking to recruit a Drug Safety Administrator to join their team This is a Technical Role for persons with a life science degree, degree in pharmacy and nursing qualifications. For this title, the Drug Safety Administrator desirable to have at least 1 year of experience as a Drug Safety Administrator or can be a recent graduate. The Drug Safety Administrator shows an understanding of the Quality Management Process with a good knowledge and understanding of applicable company policies, procedures and working practice documents.

KEY RESPONSIBILITIES & TASKS For scenarios or projects that fall outside the scope of their technical, clinical or medical expertise should be escalated or in certain circumstances pre-checked by a senior or more technically qualified colleague before final release. Keeping the Pharmacovigilance Manager fully informed of problems and issues that may arise related to the product, adverse events, the patients, prescribers or the marketing authorisation holder.

In the absence of Drug Safety Associate, the Drug Safety Administrator escalates these issues to a senior or more technically qualified staff member for their clinical input and guidance, as required. Upload Pro Quest alerts for assigned active ingredients into the Literature Monitoring System (LMS). Identifying case reports and important safety information/published studies in the LMS database. Processing selected case reports in the ICSR database.

Checking all literature case reports have the appropriate AE terms assigned for MedDRA coding. Notifying the QPPV of cases where the appropriate MedDRA term cannot be identified independently. Reconciliation both with clients and/or with PV partners on behalf of clients (as required). Screening of Published Literature & the MLM Service Individual Case Safety Reports Processing ICSR reports from any source in the drug safety database.

Attaching source documents with each case on the drug safety database. Exchanging a PV case reference from the ICSR database and exchanging these with PV partners. Conducting follow–up investigation for direct reports from either patients or healthcare professionals. Exchanging a PV case reference from the ICSR database and exchanging these with PV partners. Conducting follow–up investigation for direct reports from either patients or healthcare professionals.

Qualifications – The ideal person will must have a Life Science Degree either a recent graduate looking to secure their second job, or has a nursing degree or experience Please note only CV’s with these qualifications or experience will be considered. Has a life science degree and is either a recent graduate or looking to secure their second job. Candidates must be located within commuting distance of either Bedfordshire, Buckinghamshire, or Northamptonshire.