Work Preference
Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Deepak Ghogare
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Deepak Ghogare

Pune

Work Preference

Job Search Status

Open to work
Desired start date: Open to discussion

Desired Job Title

Operation specialist IISafety and Pharmacovigilance Specialist IISafety Science Coordinator IIDrug Safety Associate

Work Type

Full TimePart Time

Location Preference

On-SiteRemoteHybrid
Open to relocation: Yes

Important To Me

Career advancementCompany Culture

Summary

Results-driven Pharmacovigilance professional with 7+ years of experience in drug safety operations, specializing in ICSR processing, quality management, team mentoring, and regulatory compliance. Demonstrated success in leading training initiatives, managing case allocations, monitoring productivity and quality metrics, driving RCA/CAPA and process improvements, and supporting audit readiness. Proficient in ARGUS Safety Database, MedDRA, and WHO-DD, with a strong track record of collaborating across functions to deliver high-quality pharmacovigilance operations.

Overview

7
7
years of professional experience

Work History

Operation specialist II

IQVA
Pune
09.2025 - Current
  • Investigated delayed ICSR submissions, identified root causes, and implemented preventive actions to improve compliance with regulatory reporting timelines.
  • Managed daily ICSR case allocations to ensure balanced workload distribution, optimal resource utilization, and timely case processing.
  • Performed Root Cause Analysis (RCA) for quality issues and collaborated with cross-functional teams to implement Corrective and Preventive Actions (CAPA), reducing recurring errors.
  • Collaborated with cross-functional teams to streamline workflows, implement process improvements, and enhance team efficiency while reducing quality issues.
  • Assisted in preparing and analyzing team performance metrics, including productivity, quality, and turnaround time (TAT), to support performance monitoring and continuous improvement.
  • Assisted in drafting, reviewing, and approving Data Entry Instructions to ensure consistency, accuracy, and compliance with pharmacovigilance procedures.

Safety and Pharmacovigilance Specialist II

Syneos Health
Pune
03.2023 - 09.2025
  • Performed quality control reviews of Individual Case Safety Reports (ICSRs), ensuring data accuracy, completeness, and compliance with global regulatory requirements.
  • Developed and implemented process improvements (mentorship process) that enhanced case quality, reduced processing errors, and increased overall team efficiency.
  • Developed and implemented best practices to improve team efficiency and reduce errors in ICSR handling and reporting
  • Delivered pharmacovigilance training on ICSR processing, MedDRA coding, and narrative writing to new and existing team members.
  • Supported internal and external PV audits by maintaining training compliance records and ensuring accurate documentation.

Safety Science Coordinator II

Fortrea (Labcorp)
Pune
03.2021 - 03.2023
  • Processed and performed quality review of Individual Case Safety Reports (ICSRs), including spontaneous and regulatory cases, using the ARGUS Safety Database.
  • Implemented quality-focused practices to improve data accuracy and ensure compliance with global regulatory requirements.
  • Mentored team members on ICSR processing and conducted training on MedDRA, WHO-DD, and ARGUS Safety Database to enhance technical expertise and ensure compliance with pharmacovigilance standards.
  • Performed literature screening to identify adverse event reports and supported the preparation of aggregate safety reports (PSURs, PBRERs, and DSURs).
  • Supported internal and external pharmacovigilance audits by maintaining accurate safety documentation and training compliance records.

Drug Safety Associate

TATA Consultancy Services
Pune
01.2019 - 02.2021
  • Accountable for data entry and quality review of individual case safety reports (ICSRs) in the ARGUS Safety Database, including spontaneous, PMS, MRP, Literature ICSRs.
  • Conducted systematic literature reviews to identify relevant adverse event reports from scientific literature sources (Literature screening).
  • Trained on writing on different type of aggregate reports including PBRER/PSUR, DSUR.
  • Accountable to maintain and support team to complete training activity.

Education

M. Pharmacy - QAT

Savitribai Phule Pune University
Alard College Of Pharmacy
01-2018

B. Pharmacy - Distinction

SRTMU Nanded
VDF School Of Pharmacy
01-2016

D. Pharmacy - First Class

MSBTE Mumbai
SBNM College Of Pharmacy
01-2013

Skills

ICSR Processing & Quality Review

ARGUS Safety Database

MedDRA & WHO-DD Coding

Pharmacovigilance Operations

Aggregate report support

Literature Screening

RCA & CAPA

Internal & External Audit Support

ICSR workload management

Productivity, Quality & TAT Monitoring

Process Improvement

Cross-functional Collaboration

Team Mentoring & Training

Documentation Review

Audit Readiness

Resource Planning

Adaptability

Decision Making

Accomplishments

  • Received the Quality Master Award for excellence in quality and compliance.
  • Recognized as Quarter Star and Star Performer for outstanding individual performance.
  • Received Star Team and BPS Champions Team awards for contributing to high-performing team excellence.
  • Recognized for implementing best practices that improved team performance, quality, and operational efficiency.

Timeline

Operation specialist II

IQVA
09.2025 - Current

Safety and Pharmacovigilance Specialist II

Syneos Health
03.2023 - 09.2025

Safety Science Coordinator II

Fortrea (Labcorp)
03.2021 - 03.2023

Drug Safety Associate

TATA Consultancy Services
01.2019 - 02.2021

M. Pharmacy - QAT

Savitribai Phule Pune University

B. Pharmacy - Distinction

SRTMU Nanded

D. Pharmacy - First Class

MSBTE Mumbai

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