IQVIA is hiring for the role of Periodic Report Exp Oversight (PRE) in Bangalore and Thane. This position plays a crucial role in pharmacovigilance (PV) and regulatory compliance, ensuring timely and accurate submission of Periodic Safety Reports (PSRs).
Key Responsibilities:
- Provide Global PSR format training to new staff and contributors.
- Act as a Subject Matter Expert (SME) during inspections and audits.
- Implement process improvements and updates to Quality Documents (QDs).
- Coordinate with regulatory and clinical teams to compile PV content, including Risk Management Plans (RMPs) and signal detection analyses.
- Lead cross-functional teams to ensure timely PSR submissions.
- Oversee vendor-managed PSRs, ensuring adherence to quality standards.
- Maintain documentation in Sanofi’s document management system.
- Participate in Health Authority (HA) assessment report responses.
- Track compliance metrics and support root cause analysis for deviations.
- Ensure timely escalation of potential delays in PSR submissions.
Qualifications & Skills:
- Strong experience in pharmacovigilance, regulatory reporting, or drug safety.
- Knowledge of Periodic Safety Reports (PSRs) and Risk Management Plans (RMPs).
- Ability to work with cross-functional teams and vendors.
- Excellent documentation and compliance oversight skills.
- Familiarity with global regulatory requirements (EMA, FDA, etc.).
About IQVIA
IQVIA is a world leader in clinical research, healthcare analytics, and commercial solutions for the life sciences industry. We help accelerate drug development and improve patient outcomes through data-driven insights. With a presence in over 100 countries, IQVIA is at the forefront of healthcare innovation.
How to Apply
If you meet the qualifications and are interested in this Periodic Report Exp Oversight (PRE) role, apply before the deadline:
📅 Last Date to Apply: May 22, 2025
📍 Locations: Bangalore / Thane
📌 Job ID: R1481681
