Case processing professional responsible for end-to-end ICSR processing within a large-volume OTC/consumer healthcare pharmacovigilance program, predominantly non-serious 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