
Submission Specialist
4 days ago
RESPONSIBILITIES
- Book-in, Data Entry and Quality Reviewer of ICSR in Argus database
- ICSR Global Submission (Timelines and Submission Process)
- Vendor Management
- SOP training in department as and when needed
DESIRED SKILLS
- Good knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines.
- Good knowledge about timelines and submission process of Global ICSRs w.r.t to multiple health authorities.
- Good knowledge about Global submission mailbox, maintenance of submission data and trackers of all ICSR submission activities including correspondence with regulatory authorities and submission records for audits and inspection readiness.
- Basic knowledge of Computers
- Good Communication skills
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