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 ProQuest 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.
