Hire Sweta

Sweta Taral

Senior Safety & Pharmacovigilance Specialist

Sweta Taral is a Senior Safety & Pharmacovigilance Specialist with 9 years of experience across end-to-end ICSR case processing, quality review, compliance, and team leadership in clinical and post-marketing environments. Skilled in MedDRA/WHODD coding, CAPA, workflow management, and regulatory frameworks (GVP, ICH-GCP), she drives operational excellence, ensures audit-ready documentation, and mentors teams while collaborating with cross-functional stakeholders.

FORMERLY AT

Syneos Health

LOCATION

Bengaluru, India

AVAILABILITY

Full-time

Skills

Argus

ARISg

Audit Readiness

CAPA/RCA

Client/Investigator Coordination

ICSR Processing & QC

InForm

MedDRA

Medidata

MS Office

Reconciliation

WHO-DD

Work Experience

Drug Safety & PV Specialist

Tata Consultancy Services (TCS)

July 2019 – September 2022

Handled end-to-end case processing, triage, QC review, and case reconciliation between safety and clinical databases (Medidata, Inform).
Supported PV agreement tracking, sponsor/investigator communications, and SLA compliance.
Organized weekly quality huddles and developed standardized case processing checklists.

TECHNOLOGIES

Medidata, Inform, ICSR Processing/QC, Reconciliation, Client/Investigator Coordination

Operations Specialist I

IQVIA

October 2016 – July 2019

Managed mailbox monitoring, case acknowledgements, and closure communications. Processed ICSRs including unblinding, duplicate merging, and protocol updates across therapeutic areas.
Coordinated with medical reviewers to ensure regulatory submission compliance.

TECHNOLOGIES

ICSR Processing, Compliance Tracking, Medical Reviewer Coordination