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Vaishali Pathak

@vaishalipathak1

Senior pharmacovigilance and aggregate reporting specialist delivering compliant EU/US safety submissions through signal evaluation and medical writing.

India

Message

What I'm looking for

I’m looking to lead end-to-end EU/US aggregate safety submissions—owning PBRER/DSUR/PADER strategy, signal evaluation, and benefit–risk narratives—within a cross-functional team that values inspection-ready quality and timely delivery.

I’m a strategic, detail-oriented Pharmacovigilance professional with 7+ years of global experience, currently positioned as a Senior Safety & Pharmacovigilance Specialist across EU/US sponsor environments. I lead end-to-end lifecycle management of high-complexity aggregate safety reports—PBRERs, DSURs, PADERs, and ASRs—while ensuring compliance with ICH, EMA, FDA, and GVP standards. I also drive benefit–risk evaluation and safety signal integration, translating cumulative data into regulatory-grade, executive-level conclusions.

Previously, at Symogen Private Limited, I executed end-to-end ICSR processing (case triage, medical review, seriousness assessment, and MedDRA coding using Argus Safety) and supported signal detection through spontaneous reports, literature, and clinical trial data. I bring a strong quality and inspection mindset: I perform critical medical and QC reviews, support inspection preparation with traceability and compliance, and mentor others on aggregate reporting standards and regulatory writing best practices.

Experience

Work history, roles, and key accomplishments

Current

Senior Safety & Pharmacovigilance Specialist

Current

Syneos Health Private Limited

Nov 2021 - Present (4 years 7 months)

Led end-to-end development and QC of complex aggregate safety reports (PBRERs, DSURs, PADERs, ASRs) for EU/US sponsors, ensuring compliance with EMA, FDA, ICH and GVP Module VII and delivering submission-ready documents on aggressive timelines. Performed benefit–risk evaluation, signal integration, and critical medical/QC reviews to support inspection readiness with no critical findings.

GVP Module VII Safety Data Reconciliation & Validation QC Review & Submission Readiness

Drug Safety Associate

Symogen Private Limited

Oct 2019 - Nov 2021 (2 years 1 month)

Executed end-to-end ICSR processing in Argus Safety, including case triage, medical review, seriousness assessment and MedDRA coding, and authored causality narratives aligned with EU and US regulatory requirements. Supported signal detection, periodic safety report preparation, and PV SOP development/internal audits.

MedDRA Coding Narrative Writing Signal Detection SOP Development Internal Audit

Clinical Research Coordinator

Medanta – The Medicity

Mar 2018 - Oct 2019 (1 year 7 months)

Coordinated ICH-GCP compliant clinical trials by maintaining TMFs and tracking safety data including AEs/SAEs, concomitant medications and laboratory results to ensure protocol adherence. Managed patient screening, enrollment and follow-up and coordinated with investigators, sponsors, IRBs and vendors throughout the study lifecycle.

ICH GCP Trial Master File (TMF) Management Study Lifecycle Coordination Clinical Research Operations