Sarvesh Vinod Parolekar
Senior Drug Safety Associate
Dhule,MH
Summary
Pharmacovigilance professional with 9+ years of experience at Cognizant and TCS. Expertise in mailbox management, triage, case processing, quality control, regulatory compliance with Argus safety database. Proven ability in handling expedited cases within strict regulatory timelines while ensuring high quality standards.
Overview
9
9
years of professional experience
4
4
Certification
Work History
Mailbox Associate
Cognizant Technology Solution Pvt. Ltd
07.2018 - Current
- Mailbox Associate (2023-Present): Managed mailbox operations, including mail pulling and triage allocation for incoming volume, and executed various reconciliation types using Excel to ensure data accuracy.
- Quality Control Associate (2021-2023): Performed quality checks for ICSR and E2B cases, and narrative writing (autogenerated).
- Data Entry Associate (2018-2020): Processing of ICSR and E2B cases (duplicate check, coding of events, coding of current and historical conditions, and laboratory data using MedDRA, coding of drugs using CCDS and WHODD, causality and labelling assessment, and narrative writing (manual and autogenerated)).
- Triage Associate (2020-2021): Book in ICSR and E2B (spontaneous, PMS, company, and investigator-sponsored) types of cases (duplicate check, coding of events, coding of drugs using CCDS and WHODD, causality assessment, and labelling assessment), and follow up on query mails.
- Expedited cases and their reporting timelines.
- Regulatory guidelines and, at the same time, following strict timelines.
- Execution of the organization's standard operating procedure.
Case Processor
Tata Consultancy Services
08.2016 - 07.2018
- Data entry associate: Processing of ICSR and E2B (spontaneous, PMS, company, and investigator-sponsored cases (duplicate check, coding of events, coding current and historical conditions, and laboratory data using MedDRA, coding of drugs using CCDS and WHODD, causality and labelling assessment, narrative writing (manual and autogenerated)).
- Unblinding/Safe-track Associate: code breaking of Emergency and SUSAR unblinding requests via tools.
- Expedited cases and their reporting timelines.
- Regulatory guidelines and, at the same time, following strict timelines.
- Execution of the organization's standard operating procedure.
Education
Bachelor of Pharmacy -
DCS's A.R.A College of Pharmacy
Nagaon, Dhule, Maharashtra05-2016
Skills
- Mail Processing and Data reconciliation
- Pharmacovigilance Tools: Argus Safety, MedDRA, CCDS and WHODD
- Narrative Writing (Manual & Auto-generated)
- MS Excel, Word and Power Point
- Problem Solving and Time Management
- Adaptability, Flexibility and Teamwork
Certification
- Artificial Intelligence (AI) in Pharmacovigilance - Udemy
- AI Dashboards using Microsoft Power BI - Skill Nation
- Generative AI Foundations Certificate - upGrad
- Basic to Advanced Microsoft Excel - Skill Nation
Languages
Marathi
Hindi
English
Timeline
Mailbox Associate
Cognizant Technology Solution Pvt. Ltd
07.2018 - Current
Case Processor
Tata Consultancy Services
08.2016 - 07.2018
Bachelor of Pharmacy -
DCS's A.R.A College of Pharmacy
Interest
Founder and President - DHAGA Sevabhavi Sanstha, Dhule
Active Volunteer (3+ years) - UMANG Foundation, Mumbai