Case processing skilled responsible for end-to-end ICSR processing within a large-volume OTC/consumer healthcare pharmacovigilance program, predominantly non-reliable cases. An entry-level scientific role covering the full case lifecycle, with structured training provided
Qualification and Experience:
Degree in Pharmacy, Pharm D, BHMS, BDS or equivalent preferred
At least 6 months of related experience in pharmacovigilance, drug safety, or allied clinical, scientific, or safety domains (trainable)
Key Responsibilities:
Perform case intake, book-in, triage, and validity assessment in line with program SOPs.
Carry out ICSR data entry, MedDRA coding, and narrative writing as per defined timelines.
Manage E2B submissions and case follow-up activities.
Maintain quality and compliance across all activities.
Escalate complex or potentially reliable cases appropriately.
Participate in training and development to build case processing competency.
Key Skills:
End-to-end case processing - intake, triage, submission, data entry, follow-up
MedDRA coding
Narrative writing
Safety database knowledge - Argus, LSMV, Veeva or equivalent
Quality and compliance
Consumer health
📌 Pv Scientist Case Processing Mumbai
🏢 Soterius
📍 Mumbai
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