Summary
Overview
Work History
Education
Skills
Websites
Certification
Projects And Research Papers
Timeline
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Divyanka Dubey

Divyanka Dubey

Bengaluru

Summary

Dedicated and detail-oriented Pharmacovigilance professional with extensive experience in drug and device safety. Proven expertise in managing adverse event reporting, regulatory compliance, and causality assessments. Skilled in clinical data management, signal detection, and employing database tools for efficient data management. Strong team leader with a passion for research, drug safety, and quality control.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Senior Executive - Pharmacovigilance

Meril Lifesciences
04.2024 - Current
  • Lead and mentor the pharmacovigilance team in managing adverse event (AE) reporting, ensuring data integrity and compliance.
  • Oversaw comprehensive assessment and processing of Individual Case Safety Reports (ICSRs), including MedDRA coding and expectedness evaluation.
  • Coordinated with regulatory bodies for safety data submissions, ensuring compliance with global standards.
  • Implemented signal detection methodologies to identify and assess potential safety risks.
  • Developed training programs for new hires, enhancing team competency in pharmacovigilance operations.
  • Created and updated Standard Operating Procedures (SOPs) to align with current regulatory standards and best practices.

Executive - Pharmacovigilance

Meril Lifesciences
07.2023 - 04.2024
  • Managed receipt, triage, and review of adverse event reports, ensuring accuracy and regulatory compliance.
  • Conducted thorough causality assessments and expectedness evaluations based on reference safety information (RSI).
  • Collaborated with clinical and regulatory teams to streamline case processing and reporting.
  • Maintained safety databases, ensuring data accuracy and regulatory readiness.
  • Supported risk management activities to identify and mitigate safety risks.

Device Safety Associate

Meril Lifesciences
05.2022 - 06.2023
  • Conducted surveillance of medical device safety, managing device-related adverse event reporting and evaluation.
  • Applied MedDRA coding to determine seriousness and reportability of device incidents.
  • Prepared and submitted regulatory safety reports, ensuring compliance with global standards.
  • Assisted in the development and execution of risk management plans (RMPs) for medical devices.
  • Collaborated with clinical and regulatory teams for alignment in safety monitoring and reporting.

Drug Safety Associate

IQVIA
02.2021 - 05.2022
  • Managed adverse event data within the Argus safety database, ensuring accuracy and regulatory adherence.
  • Performed triage and prioritization of case reports, focusing on seriousness and regulatory timelines.
  • Conducted quality checks and data reconciliation for consistency in safety reporting.
  • Provided operational support, including case processing tasks and cross departmental communication.
  • Contributed to training materials development and conducted onboarding sessions for new staff.

Education

Diploma in Clinical Research And Pharmacovigilance -

Bangalore Clinical Research Institute
02-2021

M.Sc. - Biochemistry

The Oxford College of Science
Bengaluru
01.2020

B.Sc. - Biotechnology

Career College of Medical Sciences
Madhya Pradesh
01.2018

Skills

  • Pharmacovigilance Operations
  • Medical Device Safety
  • Regulatory Compliance
  • Clinical Data Management (CDM)
  • MedDRA Coding
  • Signal Detection
  • Causality Assessment
  • Expectedness Assessment
  • Safety Database Management
  • SOP Development
  • Risk Management
  • Quality Assurance
  • Case Processing
  • Cross-Functional Collaboration
  • Training & Mentorship

Certification

  • Advanced Diploma in Clinical Research & Pharmacovigilance (ADCR), 2021
  • Landmark Trial Appreciation Certificate, 2023

Projects And Research Papers

  • Mushroom Cultivation
  • Wine Preparation

Timeline

Senior Executive - Pharmacovigilance

Meril Lifesciences
04.2024 - Current

Executive - Pharmacovigilance

Meril Lifesciences
07.2023 - 04.2024

Device Safety Associate

Meril Lifesciences
05.2022 - 06.2023

Drug Safety Associate

IQVIA
02.2021 - 05.2022

Diploma in Clinical Research And Pharmacovigilance -

Bangalore Clinical Research Institute

M.Sc. - Biochemistry

The Oxford College of Science

B.Sc. - Biotechnology

Career College of Medical Sciences

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Divyanka Dubey