Hire Prathik

Prathik Kawale

Senior Safety & Pharmacovigilance Specialist

Prathik Kawale is a Senior Safety & Pharmacovigilance Specialist with 9+ years of experience in ICSR case processing, quality control, CAPA, and compliance with global regulatory standards (ICH-GCP, E2B, SAE). He leads workflow coordination, training, and audit readiness activities while driving process improvements in global pharmacovigilance operations. Skilled in Argus, ARISg, and Oracle Safety, she ensures data accuracy, regulatory compliance, and seamless collaboration with cross-functional and client teams.

FORMERLY AT

Syneos Health

LOCATION

Pune, India

AVAILABILITY

Full-time

Skills

Argus

ARISg

Audit Readiness

CAPA/RCA

ICSR Case Processing

MedDRA Coding

MS Excel/PowerPoint

Oracle Safety

SOP Compliance

Workflow & Tracker Management

Work Experience

Senior Safety & Pharmacovigilance Specialist

Syneos Health

May 2023 – Present

Review ICSR cases for accuracy and compliance. Manage workflow allocation and coordination across global affiliates.
Prepare error rate reports, track quality metrics, and implement CAPA for audit observations.
Lead training, onboarding, and SME programs while ensuring SOP compliance and maintaining Business Continuity Plans.

TECHNOLOGIES

Argus, ARISg, Oracle Safety, MedDRA Coding, CAPA/RCA, SOP Compliance, Audit Readiness

Data Analyst / Trainer / Quality SME – Pharmacovigilance

Cognizant Technology Solutions (Mumbai / Argentina / Pune)

April 2016 – May 2023

Managed daily intake and case workflow for safety operations.
Conducted peer QC checks, RCA, and CAPA implementation. Monitored reconciliation, handled workload allocation, and ensured regulatory timeline compliance.
Led onboarding and refresher training sessions and supported content creation for client training documentation.

TECHNOLOGIES

ICSR Case Processing, Workflow & Tracker Management, MedDRA Coding, MS Excel/PowerPoint