Open To Work
ANAM TANIYA S
Bengaluru
Work Preference
Summary
Pharmacovigilance professional with ~3 years of experience in global drug safety operations at Accenture, specializing in end-to-end ICSR processing, medical coding (MedDRA & WHO-DD), quality review, and regulatory compliance. Hands-on experience in Argus Safety database supporting case intake, triage, seriousness and expectedness assessment, duplicate detection, literature review, and expedited reporting in compliance with FDA, EMA, and ICH-GVP guidelines.
Overview
3
3
years of professional experience
1
1
Certification
Work History
PHARMACOVIGILANCE SERVICE ANALYST
Accenture
Bengaluru
2025.09 - Current
- Reviewed ICSRs for accuracy, completeness, and compliance with FDA and EMA regulations.
- Performed detailed case assessments, including seriousness, causality, and expectedness, using USPI and SmPC.
- Conducted quality reviews of invalid cases, ensuring adherence to SOPs and regulatory standards.
- Identified and resolved discrepancies to maintain high-quality case processing.
- Ensured accurate MedDRA and WHO-DD coding for adverse events and products.
- Supported regulatory audits and inspections with documentation and process expertise.
- Mentored and trained junior associates on ICSR workflows and pharmacovigilance best practices.
- Led training sessions on literature review and regulatory submissions.
- Performed case triage and prioritized cases based on seriousness and reporting timelines.
- Managed pharmacovigilance mailboxes for timely intake and routing of safety cases.
- Conducted literature reviews using Article Galaxy and NCBI.
DRUG SAFETY ASSOCIATE
Accenture
Bengaluru
2024.06 - 2025.08
- Processed adverse event reports from various sources, including spontaneous, literature, NIS, PMS, legal, and PV mailbox.
- Performed case validity checks, detected duplicates, and entered data in a structured format.
- Assessed seriousness, causality, and expectedness according to USPI guidelines.
- Wrote clear and compliant case narratives.
- Sourced and evaluated scientific articles for case processing and causality assessment.
- Ensured timely submission of ICSRS following regulatory timelines on safety data and submissions.
PHARMACOVIGILANCE SERVICE ASSOCIATE
Accenture
2023.06 - 2024.06
- Reviewed reports for completeness and accuracy, ensuring compliance with regulatory standards.
- Maintained internal quality standards and regulatory requirements to support safety and efficacy in pharmacovigilance.
- Processed and prioritized ICSRS to ensure timely reporting and compliance with SOPs and project workflows.
- Documented E2B and LAM cases to ensure regulatory compliance.
- Entered and validated safety data in Argus Safety database.
Education
Master's Degree - Biotechnology
Kuvempu University
Shivamoga, Kamataka2022-11
Bachelor's Degree - Chemistry, Botany And Biotechnology
Government Women's College Kolar
Kolar2020-11
Skills
- Drug safety
- Adverse event reporting
- Quality control
- ICSR processing
- SAE and SUSAR assessment
- MedDRA coding and review
- Duplicate case analysis
- Argus safety database management
- Reporting compliance
- Regulatory expertise
- Regulatory guidelines
- Standards adherence
- Submissions support
- Audit assistance
- Clinical trial analysis
- Pharmacovigilance reporting
- Safety data evaluation
- Regulatory literature evaluation
- Data analysis
- Power BI
- Research methodologies
- Project management
- Stakeholder communication
- Team collaboration
- Attention to detail
Websites
Certification
Advanced Post-Graduate Certification in Clinical Research and Management
Languages
- English
- Kannada
- Hindi
- Urdu
- Tamil
- Telugu
Accomplishments
- Core Value Champion Award – 2024 (Accenture)
Timeline
PHARMACOVIGILANCE SERVICE ANALYST
Accenture
2025.09 - Current
DRUG SAFETY ASSOCIATE
Accenture
2024.06 - 2025.08
PHARMACOVIGILANCE SERVICE ASSOCIATE
Accenture
2023.06 - 2024.06
Master's Degree - Biotechnology
Kuvempu University
Bachelor's Degree - Chemistry, Botany And Biotechnology
Government Women's College Kolar