Hire Sonal

Sonal Kadam

Accomplished Pharmacovigilance and Clinical Safety professional with 12+ years of global experience across drug safety, signal detection, medical data review, and regulatory compliance in US, EU, and APAC markets. Skilled in ICSR case processing, MedDRA/WHODD coding, quality review, audit readiness, and risk management. Proven expertise in managing end-to-end safety operations, collaborating across regulatory, medical, and quality teams, and maintaining adherence to FDA, EMA, and MHRA reporting standards.

FORMERLY AT

Seagen, Inc

LOCATION

Hyderabad

AVAILABILITY

Full Time

Skills

Argus Safety

Audit Tracking Tools

Clinical Trial Management System (CTMS)

eCRF Systems

Excel QC Tracker

Excel Tracker

MedDRA

MedDRA Browser

Oracle Argus

SAS Data Listings

Veeva Vault Safety

WHODD

Work Experience

Case Management Specialist – Pharmacovigilance

Seagen, Inc

Oct 2022 – May 2024

Managed case processing operations including medical review and QC of ICSRs.
Conducted retrospective data reviews ensuring completeness and clinical relevance.
Supported signal evaluation, safety data analysis, and CAPA implementation.
Led audit remediation activities and acted as SME for inspection findings.
Collaborated with global vendors ensuring data integrity and compliance.

TECHNOLOGIES

Argus Safety, Veeva Vault Safety, MedDRA, WHODD, Excel QC Tracker, Audit Tracking Tools

Pharmacovigilance Associate II

Takeda (formerly Shire, Boston, MA)

Nov 2017 – Dec 2020

Performed medical and quality review of global ICSR cases per E2B (R3) and internal SOPs.
Managed vendor oversight for literature and spontaneous case review.
Ensured alignment with core data sheets (CDS) and safety narratives.
Conducted literature surveillance, QC checks, and training for PV associates.

TECHNOLOGIES

Argus Safety, Arisg, Veeva Safety, MedDRA, WHODD, SharePoint

Senior Medical Data Specialist (Medical Coder/Reviewer)

Eisai, Inc (Woodcliff Lake, NJ)

Oct 2016 – Oct 2017

Conducted medical coding and review using MedDRA and WHODD standards.
Validated data for accuracy, clinical context, and regulatory compliance.
Partnered with data management for discrepancy resolution and data integrity.