Summary
Overview
Work History
Education
Skills
AWARDS
LANGUAGES
WEBSITES
DECLARATION
Timeline
Generic

Mangesh Potewar

Nanded

Summary

Seasoned Pharmacovigilance Associate with a robust background in MedDRA coding and data analysis, honed at Apcer Life Science. Excelled in enhancing drug safety processes and compliance, demonstrating a keen eye for detail and a strong command of ARGUS database management. Proven ability to lead with precision and communicate effectively, ensuring quality and regulatory adherence in fast-paced environments.

Overview

3
3
years of professional experience

Work History

Pharmacovigilance Associate Level III

Apcer Life Science
Ahmedabad
09.2024 - Current
  • Working in the Quality and Compliance team, and downloading the EV web regulatory cases.
  • Monitored and addressed pending individual case safety reports (ICSRs).
  • Managing the drug safety mailbox and event assessment activity.
  • Triaging and intake of Individual Case Safety Reports (ICSRs).
  • Case Types Handled: Spontaneous, Post-Marketing Surveillance (PMS).
  • Booked in/intake and triaged Individual Case Safety Reports (ICSRs) in safety databases and automated tools.
  • Advanced the skills in medical terminology and MedDRA coding, using the ARGUS safety database.

Junior Data Analyst (Quality Reviewer)

Cognizant
Mumbai
06.2023 - 07.2024
  • Conducted quality checks on ICSRs and offered constructive feedback.
  • Ensured accurate coding of provided description into standard medical dictionaries and nomenclature including MedDRA and WHO Drug Global.
  • Ensure compliance (quality, procedures,regulations, timeliness, consistency)with
    local regulations and Company’s global Pharmacovigilance requirements.
  • Confirm and assess coding of suspect products, concomitants, events and
    seriousness in ARGUS data base.
  • Maintain necessary peer, client communication related to case processing.

Trainee Junior Data Analyst (Case Processor)

Cognizant
Mumbai
03.2022 - 06.2023
  • Worked on various case types including post marketing study, E2B, spontaneous, and clinical trial cases.
  • Proficient in utilizing ARGUS DATABASE v 8.1.2 (client specific database) for adverse event case assessment, MedDRA coding, and narrative writing.
  • Analyzed source documents (CIOMS, Med-Watch, XML file) and accurately entered medically relevant information into safety database fields.
  • Managed end-to-end case processing, including data entry, adverse event pulling, and coding of adverse events and drugs using MedDRA, CPD, and WHODD.
  • Prioritized cases to maintain TAT/ timeline for report submission to authorities, distributors, and licensing partners.
  • Experienced in data correction and health Canada activities.

Education

Post Graduation Diploma in Regulatory Affairs -

Maharashtra Institute of Pharmacy, WPU University
Pune, India
2021

Bachelor Of Pharmacy -

R.C.Patel Institute of Pharmaceutical Education and Research Center
Shirpur, India
2020

Higher Secondary School Certificate - Biology

Blue Bells Junior College Waman Nagar, Nanded
Nanded, India
2016

Secondary School Certificate -

Madhavrao Patil Highschool Rajgad Nagar, Nanded
Nanded, India
2014

Skills

  • MedDRA coding (proficient in coding adverse events), medical history, and lab data
  • Data analyst (analyzing the reports, classifying them, and entering them into the structured field in an orderly manner)
  • Report assessment (experienced in processing regulatory authority cases, post-marketing, and spontaneous reports)
  • Technically equipped (skilled in working with MS Office, MS Excel, and PowerPoint)

AWARDS

Awarded as a Star performer of the month in Quality control

LANGUAGES

English                                  Hindi

Marathi

WEBSITES

https://www.linkedin.com/in/mangesh-potewar-631170147

DECLARATION

I hereby declare that the information furnished above is true to the best of my knowledge.

                                                                                                                    Mangesh Potewar

                                                                                             

Timeline

Pharmacovigilance Associate Level III

Apcer Life Science
09.2024 - Current

Junior Data Analyst (Quality Reviewer)

Cognizant
06.2023 - 07.2024

Trainee Junior Data Analyst (Case Processor)

Cognizant
03.2022 - 06.2023

Post Graduation Diploma in Regulatory Affairs -

Maharashtra Institute of Pharmacy, WPU University

Bachelor Of Pharmacy -

R.C.Patel Institute of Pharmaceutical Education and Research Center

Higher Secondary School Certificate - Biology

Blue Bells Junior College Waman Nagar, Nanded

Secondary School Certificate -

Madhavrao Patil Highschool Rajgad Nagar, Nanded

Similar Profiles

CREATE PROFILE
Mangesh Potewar