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Operations Specialist Role at IQVIA – Safety Data Processing

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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.

๐Ÿ“ Location: Kolkata, India
๐Ÿ“… Application Deadline: July 25, 2025 (2 days left)
๐Ÿ“Œ Job ID: R1473809


Detailed Job Description

Key Responsibilities:

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

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Required Skills:

๐Ÿ”น Advanced knowledge of pharmacovigilance regulations (ICH-GCP, GVP).
๐Ÿ”น Proficiency in safety databases (Argus, ARISg, Veeva).
๐Ÿ”น Strong medical terminology & coding (MedDRA, WHO-DD).
๐Ÿ”น Leadership & mentoring abilities.
๐Ÿ”น Excellent communication & problem-solving skills.


Eligibility & Qualifications

Education & Experience:

๐ŸŽ“ Bachelorโ€™s degree in Life Sciences, Pharmacy, or related field.
๐Ÿ’ผ 3-5 years of pharmacovigilance experience.

Preferred Skills:

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


Benefits & Work Culture

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


How to Apply

Application Link

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