IQVIA is hiring a PV Publishing Specialist in Bangalore, India, and Thane, Maharashtra, India. This is a full-time role where you will be responsible for managing pharmacovigilance (PV) reports, ensuring compliance with regulatory standards, and working with electronic document management systems (eDMS).
Key Responsibilities:
- Import, create, publish, and perform QC checks on Periodic Safety Reports (PSRs) in the eDMS system.
- Train and mentor new team members on eDMS and Microsoft Word functionalities.
- Ensure PV reports are authored, versioned, and approved as per ICH guidelines.
- Manage report publishing in Calyx RIM, perform quality checks, and escalate delays.
- Act as an eDMS Subject Matter Expert (SME) for audits, inspections, and process improvements.
- Update Quality Documents (QDs) and implement quality improvement actions.
- Support internal and partner audits, ensuring compliance with regulatory requirements.
About IQVIA
IQVIA is a global leader in clinical research, healthcare analytics, and commercial solutions for the life sciences industry. We help accelerate drug development and commercialization, improving patient outcomes worldwide. With a strong presence in over 100 countries, IQVIA is at the forefront of healthcare intelligence and innovation.
