IQVIA is hiring an Operations Specialist 1 for its Pharmacovigilance (PV) and Drug Safety team in Kolkata and Kochi. This role involves reviewing, assessing, and processing safety data from clinical trials and post-market surveillance, ensuring compliance with global regulatory standards.
Key Responsibilities:
✔ Process and manage Safety Data (ICSRs – Individual Case Safety Reports) in compliance with ICH E2B, CIOMS, and MedWatch guidelines.
✔ Perform regulatory submissions to Health Authorities, Ethics Committees, and Investigative Sites within timelines.
✔ Track and report Adverse Events (AEs), SUSARs (Serious Unexpected Adverse Reactions), and endpoint data.
✔ Generate CTMS listings, prepare alert letters, and ensure eTMF (Electronic Trial Master File) documentation.
✔ Liaise with clinical teams, investigators, and vendors for expedited reporting.
✔ Maintain 100% compliance with SOPs, IQVIA guidelines, and global pharmacovigilance regulations.
✔ Support team mentoring, process improvements, and departmental initiatives.
Qualifications & Skills Required
✅ Education:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- High School Diploma + relevant experience may be considered.
✅ Experience:
- 2+ years in Pharmacovigilance, ICSR processing, or Regulatory Submissions.
- Experience in Clinical Trial & Post-Market Safety Reporting (E2B R3, EVWEB, CIOMS, MedWatch).
- Knowledge of automated safety databases, regulatory intelligence, and medical terminology.
✅ Technical Skills:
- Proficiency in Microsoft Office, safety databases, and web-based applications.
- Ability to handle XML files, E2B gateway submissions, and portal uploads.
✅ Soft Skills:
- Strong attention to detail, time management, and problem-solving.
- Excellent verbal/written communication.
- Ability to work in shifts and meet strict deadlines.
About IQVIA
IQVIA is a global leader in clinical research, healthcare analytics, and commercial solutions for the life sciences industry. With a presence in 100+ countries, IQVIA accelerates drug development, regulatory compliance, and patient outcomes through data-driven insights.
How to Apply?
📌 Last Date: June 23, 2025
