DRUG SAFETY ADMINISTRATOR - PERMANENT, MILTON KEYNES

Salary £27-£28K

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 should have at least 1 year of experience as a Drug Safety Administrator or can be a recent graduate. The Drug Safety Administrator should show 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, escalate or, in certain circumstances, pre-check with a senior or more technically qualified colleague before final release.
• Keep 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, escalate these issues to a senior or more technically qualified staff member for their clinical input and guidance, as required.
• Upload ProQuest alerts for assigned active ingredients into the Literature Monitoring System (LMS). Identify case reports and important safety information/published studies in the LMS database.
• Process selected case reports in the ICSR database.
• Check that all literature case reports have the appropriate AE terms assigned for MedDRA coding. Notify the QPPV of cases where the appropriate MedDRA term cannot be identified independently.
• Reconcile with clients and/or PV partners on behalf of clients (as required).