Careers
:
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
| Activity |
|---|
| 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. |
| Competencies: |
|---|
| Good medical knowledge and good written as well as verbal communication skills Attention to detail and good scientific background |