Jubilant Generics Limited (JGL) is a wholly-owned subsidiary of Jubilant Pharma Limited, a global integrated pharmaceutical company. With a strong presence in Specialty Pharmaceuticals, Generics, and APIs, Jubilant serves customers worldwide.
Job Highlights
✔ Experience Required: 3+ years in the pharmaceutical industry
✔ Key Skills: Regulatory affairs, clinical data management, ICH-GCP compliance
✔ Role: Manage regulatory submissions, ensure pharmacovigilance compliance
✔ Location: Greater Noida (USFDA-approved facilities)
Job Description: Executive – Pharmacovigilance
Key Responsibilities:
- Ensure compliance with ICH-GCP, GVP, and global pharmacovigilance regulations
- Manage regulatory submissions for drug safety and adverse event reporting
- Collaborate with cross-functional teams for clinical data management
- Prepare and review Periodic Safety Update Reports (PSURs), PADER, and DSURs
- Conduct signal detection and risk management activities
- Maintain pharmacovigilance databases and ensure timely reporting to health authorities
Required Skills & Qualifications:
- Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field
- 3+ years in pharmacovigilance, regulatory affairs, or drug safety
- Strong knowledge of MedDRA, WHO-DD, and Argus/Safety Databases
- Experience with USFDA, EMA, and other global regulatory guidelines
- Excellent communication and analytical skills
