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IQVIA, a global leader in clinical research and pharmacovigilance services, is inviting applications for the position of Operations Specialist 1 at its Bangalore and Thane locations. This is a full-time opportunity for life science and healthcare graduates seeking to build a strong career in Pharmacovigilance (PV) and Drug Safety Operations.
The role focuses on reviewing, processing, and managing safety data, including adverse events (AEs), in compliance with global regulatory requirements and internal SOPs. Candidates will work closely with cross-functional teams, clients, and healthcare professionals to ensure high-quality safety deliverables.
Key Responsibilities – Operations Specialist 1 (Pharmacovigilance)
- Review, assess, and process safety data received from multiple sources
- Perform pharmacovigilance activities such as AE intake, tracking, and follow-up
- Determine initial and follow-up case status
- Perform safety database entry, AE and product coding
- Write case narratives and perform literature-related PV activities
- Ensure compliance with ICH-GCP, global and local regulatory guidelines
- Maintain quality, productivity, and delivery standards
- Create, maintain, and track ICSRs as per project requirements
- Identify quality issues and escalate to senior team members
- Liaise with clinical teams, data management, investigators, and clients
- Support or perform medical review of non-serious AEs/ADRs, including:
- Expectedness and listedness
- Causality assessment
- Concomitant medications and medical history review
- Attend project meetings and mentor junior team members when assigned
- Ensure 100% compliance with IQVIA people practices and SOPs
Qualifications & Skills Required
Educational Qualification
- Bachelor’s degree in Life Sciences, Pharmacy, Healthcare, or allied scientific discipline
Experience
- 1 to 3 years of experience in pharmacovigilance, drug safety, or clinical research
- Equivalent combination of education and training is acceptable
Technical & Functional Skills
- Good knowledge of medical terminology
- Working knowledge of safety databases (Argus, ARISg, or equivalent)
- Understanding of global clinical research regulations
- Experience with AE coding, narratives, and case processing
Soft Skills
- Excellent attention to detail and data accuracy
- Strong written and verbal communication skills
- Ability to multitask and meet strict deadlines
- Team player with strong organizational skills
- Willingness to work in rotational shifts
- Flexibility to adapt to changing process requirements
Salary & Benefits
- Estimated Salary Range: ₹4,00,000 – ₹7,00,000 per annum (INR)
- Exposure to global pharmacovigilance projects
- Structured training and career development programs
- Opportunity to work with a leading CRO – IQVIA
- Health insurance and standard corporate benefits
- Inclusive, compliance-driven work culture
Job Location
- Bangalore, Karnataka, India
- Thane, Maharashtra, India
How to Apply
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