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Rajiv Patil
Senior Pharmacovigilance Specialist
Senior Pharmacovigilance Specialist
Rajiv Patil is a Senior Pharmacovigilance Specialist with 8+ years of experience in literature surveillance, ICSR processing, medical coding, and drug safety operations. He specializes in literature screening, case triage, and safety reportability assessments using MedDRA/WHODD and global regulatory frameworks (FDA, EMA, MHRA, TGA). Skilled in workflow management, CAPA support, and mentoring teams, Rajiv ensures compliant and efficient pharmacovigilance delivery for global clients
FORMERLY AT
Clarivate
LOCATION
Bangalore, India
AVAILABILITY
Full-time
Skills
CAPA Tracking
Database QC & Reconciliation
Dialog
DST
Embase
ICSR Processing
Literature Surveillance
Literature-Based ICSR Identification
MedDRA
MedDRA/WHO-DD/CPD Coding
Narrative Writing
PSUR/PBRER/RMP Support
PubMed
Veeva Vault
WHO-DD
+1 More
Work Experience
Drug Safety Scientist I
Qinecsa (formerly Bioclinica)
January 2023 – November 2024
- Handled case intake, triage, duplicate checks, and L2A review for literature-based ICSRs.
- Performed medical coding (MedDRA, WHO-DD) and causality assessment.
- Managed workflow allocation, tracking, shift scheduling, and coordinated CAPA, translations, and reconciliation.
- Trained new hires and supported audits and client calls.
TECHNOLOGIES
MedDRA, WHO-DD, CAPA Tracking, Workflow Management, Literature Surveillance
Senior Drug Safety Associate
Qinecsa (formerly Bioclinica)
April 2019 – December 2022
- Conducted literature surveillance per FDA/EMA/MHRA/TGA regulations.
- Performed QC and reconciliation of literature surveillance databases.
- Prepared literature strings for aggregate reports (PSUR, PBRER, ADCO, RMP).
- Managed user access, documentation, and UAT activities.
TECHNOLOGIES
Literature Surveillance, PSUR/PBRER/RMP Support, Database QC & Reconciliation
Drug Safety Associate
Bioclinica
March 2017 – March 2019
- Processed adverse event reports and conducted literature-based ICSR review.
- Performed medical coding using MedDRA/WHO-DD/CPD and authored case safety narratives.
- Ensured regional reporting compliance and supported literature review activities
TECHNOLOGIES
ICSR Processing, Narrative Writing, MedDRA/WHO-DD/CPD Coding
