Summary
Overview
Work History
Education
Skills
Disclaimer
Timeline
Generic

Mahesh A Mane

Pune

Summary

I am a registered pharmacist and a pharmacovigilance professional (PV) with 11 years of experience in end-to-end PV activities. A few of my responsibilities include ICSR management, quality and compliance management, audit and inspection, ISCR regulatory submission, serving as a subject matter expert, and acting as a trainer to train the team on regulatory submission as well as ICSR's. Experienced as a trainee in clinical research, with a focus on study planning, data collection, and trial management at Cadila Pharmaceuticals.

Overview

11
11
years of professional experience

Work History

Regulatory ICSR Submission Specialist

Cognizant Technology Solutions
Pune
09.2016 - Current
  • Submitted Individual Case Safety Reports (ICSR) in compliance with global pharmacovigilance regulations.
  • Handled submissions to EMA, MHRA, and Health Canada efficiently.
  • Monitored compliance and conducted late case analyses to ensure timely reporting.
  • Prepared for quality management audits to maintain operational readiness.
  • Developed Root Cause Analyses (RCAs) and Corrective and Preventive Action (CAPA) plans to resolve issues.
  • Reviewed pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs).
  • Collaborated with stakeholders to enhance quality management processes and updates.
  • Analyzed aggregate reports to identify emerging safety issues, ensuring prompt resolution.

Pharmacovigilance Scientist

Tata Consultancy Services
Pune
02.2014 - 08.2016
  • Triaged and classified ICSRs by report type, seriousness, causality, labeling, and reporting requirements.
  • Prioritized ICSRs according to regulatory standards to ensure compliance.
  • Collaborated with stakeholders to clarify necessary information for case processing.
  • Coordinated with reconciliation team and safety scientist to resolve discrepancies between clinical and safety databases.
  • Mentored new associates in case processing, quality control, and ICSR regulatory submissions.
  • Performed quality checks on both submitted and not submitted cases to maintain data integrity.
  • Actively participated in monthly regulatory submission meetings, offering constructive feedback to enhance processes.
  • Prepared minutes of meeting and maintained action item trackers from client calls.

Education

Masters in Pharmacy - Pharmacology

Pune University
Pune
06-2013

Bachelor of Pharmacy -

Pune University
06-2011

Skills

  • EU clinical trial regulations
  • USFDA
  • MHRA
  • GCP
  • GVP
  • GDPR
  • Veeva Vault Safety
  • Argus
  • Arisg
  • MedDRA coder
  • Microsoft Office
  • Power BI

Disclaimer

I do hereby declare that the above-stated details are true, complete, and correct to the best of my knowledge

Place:                                                                                              Signature

Date:                                                                                  Mahesh Ashok Mane

Timeline

Regulatory ICSR Submission Specialist

Cognizant Technology Solutions
09.2016 - Current

Pharmacovigilance Scientist

Tata Consultancy Services
02.2014 - 08.2016

Masters in Pharmacy - Pharmacology

Pune University

Bachelor of Pharmacy -

Pune University

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Mahesh A Mane