Summary
Overview
Work History
Education
Skills
Personal Information
Disclaimer
Certification
Timeline
Generic
Payal Biswas

Payal Biswas

Ahmedabad

Summary

Seasoned Pharmacovigilance Senior Executive with 7.2 years of experience leading activities to monitor and maintain the safety of pharmaceutical products. Diverse professional with expertise in ICSR, signal activity, PADER, and PBRER.

Driven to minimize adverse events, and notify appropriate parties of identified concerns. Current pursuing certification in Project Management from PMI.

Overview

2026
2026
years of professional experience
1
1
Certification

Work History

Senior Executive

Amneal Pharmaceuticals Pvt Ltd.
11.2022 - Current
  • Quality review of serious expedited cases, and management of quality review workflow as team lead.
  • Established case processing work instructions for biologics and combination product cases.
  • As an aggregate report writer, I was involved in the PADER activity, including drafting reports and creating monthly and yearly schedules.
  • Established PBRER work instruction and SOP as the company moved to ROW countries. Successfully drafted and submitted multiple PBRERs as per regulatory standards.
  • Conducted detailed signal detection activities to proactively identify emerging safety trends in marketed products. Evaluated safety profiles, wrote signal detection reports, and monitored document filing and archiving.
  • Boosted operational efficiency through implementation of lean principles, resulting in reduced waste and improved compliance and quality.
  • Cultivated a culture of continuous improvement by promoting open communication channels for feedback from all levels within the team.

Operations Specialist-1

IQVIA RDS (India) Private Limited
5 2021 - 11.2022
  • As case logger: Initial logging of all types of cases (including spontaneous, solicited, sponsored, and non-interventional studies, licensed partner cases, pregnancy, and post-pregnancy cases) into the Sapphire database after a prior duplicate search.
  • Literature review and literature search activities on a daily basis.
  • Assisted the team in literature data collection for the aggregate report, signal activity, and risk analysis.
  • Oversaw day-to-day operations, delegating tasks appropriately to ensure a smooth workflow and timely completion of projects.
  • As EMA import activity handler: Handling of the import of cases received via EMEA.
  • Data entry support personnel: Provided support as data entry personnel when required by the team.
  • Subject matter expert for duplicate search and processing of duplicate cases.
  • RCA and CAPA drafting and management.
  • Oversaw day-to-day operations, delegating tasks appropriately to ensure smooth workflow and timely completion of projects.

Pharmacovigilance Associate

Apcer Life Sciences
07.2019 - 05.2021
  • As Case Intake/Triage Member: Responsible for intake and triage of spontaneous, literature cases and clinical trial cases
  • As Case Processor/ Peer Reviewer: Responsible for data entry of individual case safety reports into safety database
  • Provided training on pharmacovigilance best practices to new team members, enhancing overall understanding and adherence to industry standards.
  • Engaged in follow-up activity of clinical trial cases.
  • Expedited case processing times by creating customized templates for common adverse event scenarios, allowing for faster completion without sacrificing detail or quality.
  • Increased department accuracy through rigorous quality control checks on ICSR entries prior to submission, minimizing the potential for errors or discrepancies.

Drug Safety Associate

We-Xel deputed at Bioclinica India Pvt. Ltd.
05.2018 - 05.2019
  • Complete data entry in Argus safety database: Improved patient safety by accurately reviewing and processing adverse event reports.
  • Reconciled discrepancies found during adverse event data entry, resolving issues promptly while maintaining data integrity.
  • Generate adverse event queries, liaise with medical reviewers and clients to agree upon queries, and send request for additional information to sites/reporter
  • Perform literature review as appropriate for post-Marketing cases
  • Boosted efficiency in handling individual case safety reports through meticulous tracking and organization.

Education

Master In Pharmacy - Drug Regulatory Affairs

Manipal College Of Pharmaceutical Sciences, MAHE
Manipal, Mangalore
07.2018

Bachelor of Pharmacy - Pharmacy

Manipal College Of Pharmaceutical Sciences, MAHE
Manipal, Mangalore
07.2016

Skills

  • Database and Expertise: Argus Safety 82 ARISg 72 Sapphire database Veeva Safety MS Office (Excel, PowerPoint, Word, Outlook, Project)
  • Hard skills: Pharmacovigilance Clinical Research ICH & GVP guidelines GCP standards MedDRA WHO-DD CIOMS MedWatch Signal detection and Risk assessment Aggregate Reports PADER PBRER Narrative writing Audit Assistance
  • Soft skills: Critical thinking Interpersonal skills Analytical skills Diagnostics skills Problem solving skills Work under pressure Stress Management Leadership Planning & Organization Project Management skills Performance improvement Operations management Mail handlling Workflow management Task assignment Performance evaluations

Personal Information

Disclaimer

I hereby declare that the information given above are true to the best of my knowledge and belief, if I get an opportunity to work in your esteemed concern I will work to the best of my ability with honesty.

Certification

Persuing Project Management certification from PMI.

Timeline

Senior Executive

Amneal Pharmaceuticals Pvt Ltd.
11.2022 - Current

Pharmacovigilance Associate

Apcer Life Sciences
07.2019 - 05.2021

Drug Safety Associate

We-Xel deputed at Bioclinica India Pvt. Ltd.
05.2018 - 05.2019

Operations Specialist-1

IQVIA RDS (India) Private Limited
5 2021 - 11.2022

Master In Pharmacy - Drug Regulatory Affairs

Manipal College Of Pharmaceutical Sciences, MAHE

Bachelor of Pharmacy - Pharmacy

Manipal College Of Pharmaceutical Sciences, MAHE

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