Summary
Overview
Work History
Education
Skills
Timeline
Accomplishments
Personal Infomation
SUNILKUMAR VANIYA

SUNILKUMAR VANIYA

Drug Safety Scientist - Deputy Manager
Ahmedabad

Summary

Experienced drug safety expert with in-depth knowledge and working experience in pharmacovigilance.
Proficient in preparing aggregate reports such as PBRER/PSUR, DSUR, and PADER.
Skilled in utilizing signal detection tools like Empirica, OFF-X, and Clarity PV.
Effective in responding to health authority inquiries and developing Risk Management Plan documents.
Specialized in evaluating drug safety in oncology and other therapeutic areas.
Experienced in handling regulatory inspections and internal audits for compliance.
Proficient in reviewing non-ICSR literature and monitoring.
Possesses advanced computer skills to enhance productivity and streamline processes.

Overview

11
11
years of professional experience
6
6
years of post-secondary education
3
3
Languages

Work History

Deputy Manager - Medical Safety

APCER Life Sciences
Ahmedabad
04.2023 - Current

Leader - Medical Safety Scientist

  • Signal Management Lead - (Done process improvements in Signaling tools - Empirica, OFF-X, Clarity PV), SOPs and Job Aid creation, Signal metrix preparation
  • Aggregate reports (PBRER/PSUR, PADER, DSUR) authoring and review
  • Health Authority responses
  • Non-ICSR literature review
  • Regulatory inspections/internal audits
  • RSI update and data sheet preparation
  • MedDRA - web browser and MVAT tool
  • Power BI and advanced Excel expertise for complex Line listing review, Excel VBA Macro and Scripts coding
  • Trainer for new joiners
  • Process improvements and automation
  • Interviewed and trained 5 of associates in 2022

Assistant Manager - Medical Safety Scientist

APCER Life Sciences
Ahmedabad
11.2020 - 03.2023

Drug safety expert:

  • Signal Management Lead - (Done process improvements in Signaling tools - Empirica, OFF-X, Clarity PV), SOPs and Job Aid creation, Signal metrix preparation
  • Aggregate reports (PBRER/PSUR, PADER, DSUR) authoring and review
  • Health Authority responses
  • Non-ICSR literature review
  • Regulatory inspections/internal audits
  • RSI update and data sheet preparation
  • MedDRA - web browser and MVAT tool
  • Power BI and advanced Excel expertise for complex Line listing review, Excel VBA Macro and Scripts coding
  • SAS programming, Putty and FileZilla

Safety Scientist

Tata Consultancy Services (TCS)
12.2013 - 11.2020
  • Preparation of aggregate reports (DSUR, PBRER, PADER, QSUR and Six monthly aggregate report) for international client
  • Signal Detection
  • Non-ICSR Literature Review
  • Health Authority Responses
  • To ensure delivery of quality reports
  • To verify and confirm deadline of individual reports
  • Quality calibration of each report
  • Trainer for new employees
  • Process improvements

Associate Medical Writer

Indegene Lifesystems
Bangalore
07.2012 - 12.2013
  • Authoring Canadian Aggregate Report (CAR)
  • Performed narrative Writing and peer review
  • Clinical Overview (CO) Authoring and Review
  • Medico-marketing: product write-ups and preparing medical slides for doctors and sales force

Education

M. S. PHARM - Biotechnology

NIPER, Mohali, Chandigarh
06.2010 - 06.2012

An attempt to refold paraoxonase-1 from inclusion bodies” As a part of my research project, I purified inclusion bodies of recombinant human Paraoxonase1, an enzyme having protective role in atherosclerosis as well as acting as bioscanvenger in organophosphorus poisoning. Further, purified inclusion bodies containing rhPON1 was subjected to various conditions like dilution, dialysis, temperature and various chemicals for proper refolding.

Bachelor of Pharmacy -

A.R.College of Pharmacy, V.V.Nagar, Anand
06.2006 - 05.2010

Skills

    Signal Detection Tools: Empirica, OFF-X, Clarity PV

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Timeline

Deputy Manager - Medical Safety - APCER Life Sciences
04.2023 - Current
Assistant Manager - Medical Safety Scientist - APCER Life Sciences
11.2020 - 03.2023
Safety Scientist - Tata Consultancy Services (TCS)
12.2013 - 11.2020
Associate Medical Writer - Indegene Lifesystems
07.2012 - 12.2013
NIPER, Mohali - M. S. PHARM, Biotechnology
06.2010 - 06.2012
A.R.College of Pharmacy, V.V.Nagar - Bachelor of Pharmacy,
06.2006 - 05.2010

Accomplishments

  • Excellence award at APCER life Sciences in 2022
  • Received Star performer award at TCS in 2016

Personal Infomation

 

  • Sex: Male
  • Status: Married
  • DOB: 11-Jan-1989

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SUNILKUMAR VANIYADrug Safety Scientist - Deputy Manager