PV Scientist - Case Processing

Soterius, Inc.; Mumbai; On-site; INR 300,000 - 450,000; Full time

Job summary

Soterius, Inc. in Mumbai seeks an entry-level Case Processing professional to support end-to-end ICSR processing within a high-volume pharmacovigilance program, focusing on predominantly non-serious cases. The role includes a structured training pathway.

You will gain hands-on experience across intake, triage, data entry, MedDRA coding, and narrative writing, with exposure to E2B submissions and quality/compliance activities, while building case-processing competency.

Qualifications

• 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).

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 serious cases appropriately.
• Participate in training and development to build case processing competency.

Skills

End-to-end case processing

MedDRA coding

Narrative writing

Safety database knowledge

Education

Pharmacovigilance/related degree

Tools

Argus

LSMV

Veeva

Job description

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 serious 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