Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Poonam Farande

Mumbai

Summary

Pharmacovigilance professional with over 6 years of experience in pharmacovigilance, ICSR, literature monitoring/review, PSMF, and SDEA skilled in adapting to various roles as required. Always willing to contribute to team success through hard work, attention to detail, and excellent organizational skills.

Overview

7
7
years of professional experience

Work History

Pharmacovigilance Executive

Crescent Pharma Limited
Thane
08.2024 - Current
  • Knowledge of the marketed status of products in the local country and reference documents (i.e., Company Product List).
  • Performed a literature search activity on PubMed
  • Prepared and reviewed the search strings for literature screening.
  • Ensured the quality and comprehensiveness of literature searches.
  • Conducted a quality check of literature abstracts and articles to ensure quality and accuracy.
  • Oversaw the identification, collection, and analysis of relevant scientific publications, clinical studies, and regulatory reports.
  • Handled the quality review position and performed a quality check (PPQC) of ICSR processed by the case processor for accuracy and completeness.
  • Reviewed and evaluated AE case information to determine the required action based on and following internal policies and procedures.
  • Provided quality feedback to team resources, and mentoring.
  • Drafted Safety Data Exchange Agreements (SDEAs) for business partners, distributors, manufacturers, etc.
  • Perform reconciliation as per SDEA timelines.
  • Developed and drafted departmental Standard Operating Procedures (SOPs).
  • Drafted Risk Management Plan (RMP)
  • Knowledge of the Pharmacovigilance System Master File (PSMF).

Drug Safety Associate

MedVigil Clinical Research (PrimeVigilance)
Mumbai
04.2023 - 07.2024
  • Worked on the Oracle Argus database.
  • Review articles and perform data entry process instructions and associated SOPs to ensure consistency of case entry and data quality standards.
  • Performed comprehensive narrative writing and case data entry according to SOPs.
  • Manage safety cases, including intake/triage, data entry, and follow-up activities, following the applicable global regulatory requirements.
  • Performed regular case reviews for all ICSRs reported from any source, including literature, post-marketing studies, and post-marketing spontaneous adverse events, to ensure complete and timely review, aligning with internal and external reporting timelines.
  • Experience in medical records/discharge summary cases.
  • Completes the assessment of literature references for aggregate reports within prescribed timelines.
  • Completes the monthly tracker with details of assessments made within the client system/tools.

Senior Process Associate (Quality Reviewer)

TATA Consultancy Services
Mumbai
12.2018 - 04.2023
  • Experienced with the Sapphire database (ARISg).
  • Responsible for the preparation and review of search strings, the review of literature hits from Embase and Insight meme, tracking of full-text articles, and translation requests.
  • Performed a literature search activity on Embase and Insight meme search engines.
  • Review of the abstract and subsequent articles received from Embase, and meeting abstracts received from Insight Meme within the regulatory timeline.
  • Performed a literature search published in global literature and medical literature, and assessed the safety data for retrieving ICSR and non-ICSR safety data.
  • Triaged and registered incoming AE reports to determine seriousness for prioritization in daily workflow.
  • Entered initial and follow-up information for individual adverse event case reports of low business risk into the global Patient Safety database, using data interpretation, coding, and writing skills in accordance with the current Data Entry Process Instructions, associated SOPs, and OPI to ensure consistency of case entry and high data quality standards.
  • Assigned the case to the appropriate Sapphire work team and case owner, as per Global Case Handling SOP.
  • Reviews literature for client consumer or pharma products for safety information, as detailed in applicable client procedures, and assesses for potential ICSR, signals, and/or meeting PBRER-PSUR criteria, as required.
  • Responsible for translation management and full-text procurement, as detailed in applicable client procedures.

Education

Bachelor of Pharmacy -

Mumbai University
Mumbai
08-2018

Skills

  • Literature review
  • Team player
  • Ability to work independently and within strict timelines
  • Quality review
  • Case management
  • Process improvement

Accomplishments

  • TCS Special Achievement Award, Jan-2020
  • TCS Star Team Award, Nov-20
  • TCS Service & Commitment Award, Dec-21
  • TCS Best Team Award, Jan-23

Timeline

Pharmacovigilance Executive

Crescent Pharma Limited
08.2024 - Current

Drug Safety Associate

MedVigil Clinical Research (PrimeVigilance)
04.2023 - 07.2024

Senior Process Associate (Quality Reviewer)

TATA Consultancy Services
12.2018 - 04.2023

Bachelor of Pharmacy -

Mumbai University

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Poonam Farande