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, or nursing qualifications. 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 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, these 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 authorization holder. In the absence of the 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). Identify case reports and important safety information/published studies in the LMS database. Process selected case reports in the ICSR database. Check 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 both with clients and/or with PV partners on behalf of clients (as required). Screen Published Literature & the MLM Service. Process ICSR reports from any source in the drug safety database. Attach source documents with each case on the drug safety database. Exchange a PV case reference from the ICSR database with PV partners. Conduct follow-up investigations for direct reports from either patients or healthcare professionals.
Qualifications The ideal candidate must have a Life Science Degree, be a recent graduate looking to secure their second job, or have a nursing degree or relevant experience.
Please note only CVs with these qualifications or experience will be considered.
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This is a Technical Role for persons with a life science degree, degree in pharmacy, or nursing qualifications. 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 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, these 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 authorization holder. In the absence of the 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). Identify case reports and important safety information/published studies in the LMS database. Process selected case reports in the ICSR database. Check 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 both with clients and/or with PV partners on behalf of clients (as required). Screen Published Literature & the MLM Service. Process ICSR reports from any source in the drug safety database. Attach source documents with each case on the drug safety database. Exchange a PV case reference from the ICSR database with PV partners. Conduct follow-up investigations for direct reports from either patients or healthcare professionals.
Qualifications The ideal candidate must have a Life Science Degree, be a recent graduate looking to secure their second job, or have a nursing degree or relevant experience.
Please note only CVs with these qualifications or experience will be considered.
#J-18808-Ljbffr
