We are hiring a PV Specialist (ICSR Clinical Trials) with expertise in pharmacovigilance and clinical trial safety reporting. The role involves ensuring compliance with global PV regulations and managing safety data for biologics and small molecule drugs.
Key Responsibilities:
✔ Ensure compliance with global PV regulatory guidelines for clinical trial SAE reporting and aggregate reporting.
✔ Manage safety database operations for accurate and timely processing of SAE reports.
✔ Review, assess, and submit SAE reports from sponsored clinical trials in accordance with regulatory requirements.
✔ Maintain high-quality documentation and ensure adherence to internal safety reporting standards.
✔ Collaborate with cross-functional teams to enhance pharmacovigilance processes.
📌 Requirements
✅ Education: M. Pharm (Mandatory)
✅ Experience: 6-12 years in ICSR (Individual Case Safety Reports) handling in clinical trials.
✅ Skills Required:
- Strong knowledge of global PV regulations (FDA, EMA, ICH-GCP).
- Hands-on experience with safety databases (Argus, ARISg, Veeva, etc.).
- Ability to manage expedited and periodic safety reports.
- Excellent communication and analytical skills.
🏢 About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories is a leading global pharmaceutical company headquartered in Hyderabad, India. Known for its innovation in generic medicines, biosimilars, and proprietary products, Dr. Reddy’s is committed to providing affordable and accessible healthcare solutions worldwide.
With a strong presence in pharmacovigilance and clinical research, the company offers excellent career growth opportunities for professionals in drug safety and regulatory compliance.
📩 How to Apply?
If you meet the qualifications and are interested in this PV Specialist – ICSR Clinical Trials role, send your updated resume to:
✉ Email: shaiksalmasultana@drreddys.com
