IQVIA India Healthcare Job Opportunity – Apply Now for the Role!
IQVIA India is offering an exciting healthcare job opportunity for experienced professionals in pharmacovigilance and safety analytics. This role focuses on safety aggregate reporting, signal management, and regulatory collaboration, making it ideal for candidates seeking growth through IQVIA careers with opportunities in major hubs such as Bangalore and across PAN India.
Job Details:
- Job Position: Safety Aggregate Report Specialist 2
- Location: Bangalore
- Work Experience: 3+ years (3–5 years preferred)
About the Company:
IQVIA is a global leader in advanced analytics, clinical research, and technology solutions for the life sciences industry. Through strong innovation and global partnerships, IQVIA careers offer professionals a chance to contribute to impactful healthcare solutions. IQVIA India supports global pharmacovigilance and lifecycle safety services, including opportunities aligned with jobs in Bangalore and PAN India locations.
Qualifications:
- Bachelor’s degree in a Healthcare discipline (Required)
- 3–5 years of relevant experience in pharmacovigilance or safety aggregate reporting preferred
Healthcare Job Description:
This healthcare job involves applying knowledge and expertise within the Safety Aggregate Report and Analytics (SARA) Center. The role includes responsibility for safety aggregate reports, literature surveillance, signal management activities, and benefit-risk management documents while ensuring compliance with defined service level agreements.
Healthcare Job – Key Responsibilities:
- Serve as the principal owner of SARA deliverables and ensure completion in compliance with SLAs
- Lead, author, and finalize aggregate reports, including PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
- Author responses to regulatory agencies and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries
- Conduct and lead literature safety surveillance for marketed and investigational products
- Assist in identifying ICSRs from literature and evaluating events of special interest
- Act as Signal Management Lead on post-marketing and clinical trial projects
- Set up, organize, document, and lead safety management teams
- Develop and update product signaling strategies
- Author and QC review signal management deliverables
- Perform signal detection, validation, and evaluation activities for timely risk identification
- Ensure complete documentation and tracking of safety signals
- Lead and QC review safety responses supporting labelling documents
- Collaborate with cross-functional teams, including Regulatory Affairs, Medical Writing, Quality, IT, Safety Operations, and QPPV/PCNL
- Participate in internal and external audits and inspections
- Report project metrics, scope changes, and client concerns to management
- Participate in project review meetings and ensure Good Documentation Practices (GDP)
- Support technology-driven and innovation-related initiatives
Must-Have Skills:
- Authoring Aggregate Reports
- Safety Aggregate Reporting
- Signal Management
- Literature Surveillance
- Regulatory Safety Writing
