Position : Drug Safety Specialist

These team members at multiple levels (Specialist/Officer/Executive) will be recruited at FHS PV unit (for Data Entry and Quality Review of ICSRs). All these employees would be having expertise and experience in case processing in ARISg and/ or ARGUS with reputed PV firms.

Experience : 1- 5 years in case processing and/ or quality review of ICSRs; experience in ARISg and ARGUS

Educational background: B. Pharm; M. Pharm, BHMS/ BAMS/ BDS

General Technical responsibilities:
Data entry Individual Case Safety Reports in ARISg
Coding using Medical Dictionary for Regulatory Activities (MedDRA) and review
Triaging of cases and timely completion as per regulatory timelines
Review of literature articles/hits for relevance and identifying valid ICSRs
Attention to detail and good scientific background
Expedited reporting and/or EU/US submissions
Review of Individual Case Safety Reports in database
Review Medical Dictionary for Regulatory (MedDRA) terms
Preparing new SOPs and updating existing SOPs whenever regulations are updated.
Additional activity based support as and when required.

Good medical knowledge and good written as well as verbal communication skills Attention to detail and good scientific background