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Operations Specialist Role at IQVIA – Safety Data Processing

Published on

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Kolkata

3-5 years

Verified Job

Online Application

IQVIA is a world leader in clinical research, healthcare analytics, and commercial solutions for the life sciences industry. With a focus on accelerating medical advancements, IQVIA provides intelligent insights to improve patient outcomes globally.

📍 Location: Kolkata, India
📅 Application Deadline: July 25, 2025 (2 days left)
📌 Job ID: R1473809


Detailed Job Description

Key Responsibilities:

✔ Process Safety Data – Review, assess, and process adverse event (AE) reports per regulatory guidelines and SOPs.
✔ Pharmacovigilance Activities – Case tracking, database entry, medical coding, narrative writing, and quality review.
✔ Regulatory Reporting – Ensure timely submission of safety reports to authorities (FDA, EMA, etc.).
✔ Project Leadership – Oversee small to medium projects, mentor junior staff, and maintain compliance.
✔ Medical Review – Assess non-serious AEs/ADRs for accuracy in causality, expectedness, and documentation.
✔ Stakeholder Coordination – Liaise with clients, investigators, and regulatory bodies.

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Required Skills:

🔹 Advanced knowledge of pharmacovigilance regulations (ICH-GCP, GVP).
🔹 Proficiency in safety databases (Argus, ARISg, Veeva).
🔹 Strong medical terminology & coding (MedDRA, WHO-DD).
🔹 Leadership & mentoring abilities.
🔹 Excellent communication & problem-solving skills.


Eligibility & Qualifications

Education & Experience:

🎓 Bachelor’s degree in Life Sciences, Pharmacy, or related field.
💼 3-5 years of pharmacovigilance experience.

Preferred Skills:

✅ Experience in risk management & safety surveillance.
✅ Knowledge of clinical research regulations.
✅ Ability to work in shifts & meet deadlines.


Benefits & Work Culture

✨ Global Exposure – Work with a leading healthcare intelligence firm.
✨ Career Growth – Training, mentorship, and leadership opportunities.
✨ Flexible Shifts – Work-life balance with adaptable schedules.
✨ Inclusive Workplace – Collaborative and innovative environment.


How to Apply

Application Link

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