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.
๐ Location: Kolkata, India
๐
Application Deadline: July 25, 2025 (2 days left)
๐ Job ID: R1473809
Detailed Job Description
Key Responsibilities:
โ Process Safety Data โ Review, assess, and process adverse event (AE) reports per regulatory guidelines and SOPs.
โ Pharmacovigilance Activities โ Case tracking, database entry, medical coding, narrative writing, and quality review.
โ Regulatory Reporting โ Ensure timely submission of safety reports to authorities (FDA, EMA, etc.).
โ Project Leadership โ Oversee small to medium projects, mentor junior staff, and maintain compliance.
โ Medical Review โ Assess non-serious AEs/ADRs for accuracy in causality, expectedness, and documentation.
โ Stakeholder Coordination โ Liaise with clients, investigators, and regulatory bodies.
Required Skills:
๐น Advanced knowledge of pharmacovigilance regulations (ICH-GCP, GVP).
๐น Proficiency in safety databases (Argus, ARISg, Veeva).
๐น Strong medical terminology & coding (MedDRA, WHO-DD).
๐น Leadership & mentoring abilities.
๐น Excellent communication & problem-solving skills.
Eligibility & Qualifications
Education & Experience:
๐ Bachelorโs degree in Life Sciences, Pharmacy, or related field.
๐ผ 3-5 years of pharmacovigilance experience.
Preferred Skills:
โ
Experience in risk management & safety surveillance.
โ
Knowledge of clinical research regulations.
โ
Ability to work in shifts & meet deadlines.
Benefits & Work Culture
โจ Global Exposure โ Work with a leading healthcare intelligence firm.
โจ Career Growth โ Training, mentorship, and leadership opportunities.
โจ Flexible Shifts โ Work-life balance with adaptable schedules.
โจ Inclusive Workplace โ Collaborative and innovative environment.
