IQVIA is a world leader in clinical research, healthcare analytics, and regulatory compliance, helping pharmaceutical and biotech companies accelerate drug development. With a presence in over 100 countries, IQVIA provides intelligent solutions to improve patient outcomes worldwide.
Detailed Job Description
Job Title: Submission Reviewer
Locations: Mumbai, Kochi, Bangalore, Kolkata
Job Type: Full-time
Posting Date: July 10, 2025
Deadline: July 11, 2025 (10 hours left)
Job ID: R1475465
Major Duties & Responsibilities
- Oversee regulatory reporting rules for drugs, devices, and vaccines to ensure compliance with global health authorities (FDA, EMA, etc.).
- Manage ICSR (Individual Case Safety Report) submissions and ensure database functionality.
- Distribute “Dear Investigator Letters” and monitor regulatory mailboxes.
- Serve as a Subject Matter Expert (SME) during audits and inspections.
- Provide training on pharmacovigilance and regulatory processes.
Key Skills Required
โ Regulatory reporting expertise (FDA, EMA, MHRA, etc.)
โ Knowledge of pharmacovigilance (PV) and drug safety
โ Experience with safety databases (Argus, ARISg, Veeva)
โ Strong attention to detail & compliance awareness
Eligibility & Qualifications
- Education: Bachelorโs/Masterโs in Pharmacy, Life Sciences, or related fields.
- Experience: 2+ years in regulatory affairs, pharmacovigilance, or drug safety.
- Skills: Proficiency in Microsoft Office, regulatory databases, and compliance tools.
Benefits of Working at IQVIA
โ
Global exposure in pharmaceutical regulatory compliance
โ
Competitive salary & benefits (health insurance, bonuses)
โ
Hybrid/remote work options (location-dependent)
โ
Career growth in a leading life sciences company
How to Apply
