Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Timeline
Generic
DEEPRAJ OJHA

DEEPRAJ OJHA

Summary

Detail-oriented Drug Safety Professional with over 3 years of experience in pharmacovigilance operations and regulatory submissions. Expertise in compliance documentation, ICH-GVP, MDR 2017 regulations, and WHO-CTD frameworks. Transitioning to Regulatory Affairs in Medical Devices/IVD, focusing on import licenses, regulatory submissions, post approval changes and committed to staying updated on MDR 2017 standards.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Safety Specialist

Syneos health
Gurugram
12.2025 - Current
  • Executed end-to-end ICSR processing, medical review, MedDRA coding, and signal detection to enhance device safety and risk evaluation.
  • Supported post-marketing surveillance documentation through trend analysis and safety data review for lifecycle management.
  • Collaborating with cross-functional teams (clinical, regulatory, quality) to ensure compliance with regulatory submission and reporting requirements.
  • Utilized knowledge of MDR 2017 in safety documentation, vigilance reporting, and regulatory compliance activities.

Pharmacovigilance Research Associate

APCER Life Science
Delhi
12.2022 - 11.2025
  • Processed 5,000+ ICSRs to ensure timely, accurate, compliant safety documentation supporting regulatory submissions.
  • Maintained compliance with ICH-GVP and global safety expectations (USFDA, EMA, MHRA, CDSCO) to uphold safety standards.
  • Performed MedDRA coding, narrative writing, case reconciliation, and quality checks to enhance data integrity for safety reporting.

Project Research Fellow

AIIMS Rishikesh
Rishikesh
01.2022 - 09.2022
  • Conducted literature review (PubMed, Embase) to enhance scientific quality and improve documentation using WHO VigiFlow.
  • Responded to medical information queries from HCPs/patients with evidence-based information to ensure accurate communication.

Education

M.S. Pharm - Pharmacology

Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences & Research
Dehradun
09-2022

B.Pharm -

Department of Pharmaceutical Sciences, Kumaun University
Nainital
07-2019

Skills

  • Safety database management (IVP, ARGUS, Aris-G, WHO-Vigiflow)
  • Adverse event reporting (Drug and Devices, MedDRA Coding)
  • Regulatory compliance and submissions of drug and devices
  • Post-market surveillance
  • Risk assessment and query response
  • MS Excel
  • MS Word
  • PowerPoint

Certification

  • Certified Medical Coder, Peraton Corporation, Present
  • Drug regulatory and compliance
  • 21 CFR Part 820-Fundamental of Quality System Regulation (QSR)

Accomplishments

  • Certificate of Appreciation, Top 1% employee at APCER Life Science, 2023
  • Top Performer, "GSK Sambhavna" Enrollment Category, Lucknow, 2019
  • Qualified UKSSSC Government Pharmacy Exam, All India Rank 28, 2015
  • Represented Uttarakhand in National Badminton, 3 times

Timeline

Safety Specialist

Syneos health
12.2025 - Current

Pharmacovigilance Research Associate

APCER Life Science
12.2022 - 11.2025

Project Research Fellow

AIIMS Rishikesh
01.2022 - 09.2022

M.S. Pharm - Pharmacology

Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences & Research

B.Pharm -

Department of Pharmaceutical Sciences, Kumaun University
DEEPRAJ OJHA