Amneal Pharmaceuticals is a global leader in generic and specialty pharmaceuticals, committed to improving patient health through high-quality, affordable medicines. With a strong presence in over 100 countries, Amneal fosters innovation, compliance, and a diverse work culture.
The Human Resources team at Amneal plays a strategic role in talent acquisition, compliance, and workforce management, ensuring the company remains a preferred employer in the pharma industry.
Detailed Job Description
Position: Executive, Pharmacovigilance & Drug Safety
Location: Ahmedabad, Gujarat, India
Job Type: Full-time
Key Responsibilities:
- Signal Management: Prepare and maintain Signal Schedules per SOPs.
- Risk Assessment: Identify, analyze, and evaluate safety signals from multiple data sources.
- ADR Documentation: Prepare product-specific Adverse Drug Reaction (ADR) reports.
- Drug Safety Reports (DSR): Author DSRs for validated signals.
- Stakeholder Communication: Share findings from signal detection activities with relevant teams.
- Regulatory Compliance: Ensure adherence to pharmacovigilance regulations and guidelines.
- Training & SOP Development: Assist in revising SOPs and training teams on signal management.
Required Skills:
✔ Advanced: Adverse Event Reporting & Signal Detection, Safety Data Analysis & Visualization
✔ Intermediate: Regulatory Medical Writing, Medical Literature Review, Regulatory Affairs Collaboration
Eligibility & Qualifications
- Education: B.Pharm, M.Pharm
- Experience: Prior experience in pharmacovigilance, drug safety, or signal management preferred.
- Industry Knowledge: Familiarity with global pharmacovigilance regulations (FDA, EMA, etc.).
Benefits of Working at Amneal
✅ Competitive salary & growth opportunities
✅ Inclusive & diverse workplace
✅ Training & professional development
✅ Compliance with global regulatory standards
How to Apply
