Open to opportunities

Pratiksha More

@pratikshamore

Message

I process high-quality safety cases and ensure global pharmacovigilance compliance.

India

Message

What I'm looking for

I'm looking for a pharmacovigilance role where I can manage end-to-end safety cases, uphold regulatory compliance and quality standards, collaborate with global teams, and continue growing in drug safety operations.

I've processed end-to-end Individual Case Safety Reports at Tata Consultancy Services and Cognizant Technology Solutions, handling serious, non-serious, spontaneous, and solicited safety cases.

I use Argus Safety, Veeva Vault, Trilogy, and Rave to perform case triage, data entry, MedDRA and WHO Drug Dictionary coding, narrative writing, follow-up, and quality review. I ensure case completeness, validity, SOP adherence, and compliance with global regulatory timelines.

I've supported global teams with complex case queries, mentored new team members, and consistently delivered productivity, accuracy, and quality targets.

Experience

Work history, roles, and key accomplishments

Drug Safety Associate

Cognizant Technology Solutions

Processed spontaneous and solicited safety cases using Veeva Vault and Trilogy databases. Performed case triage, data entry, coding, narrative writing, and follow-up requests while maintaining high data quality and regulatory compliance.

Veeva Vault ICSR Processing Triage Data Entry Coding Narrative Writing Regulatory Compliance

Senior Drug Safety Associate

Tata Consultancy Services

Performed end-to-end processing of Individual Case Safety Reports (ICSRs), including data entry, MedDRA and WHO-DD coding, narrative writing, and quality checks. Coordinated with global teams and mentored new members.

MedDRA WHO Drug Dictionary ICSR Processing Narrative Writing Quality Review Regulatory Compliance