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The healthcare and pharmaceutical sector continues to see rapid hiring, and Amneal Pharmaceuticals has announced two premium openings in Ahmedabad, Gujarat. These roles offer excellent career growth for professionals in pharmacovigilance, clinical research, ICSR processing, and clinical trial management.
If you are an experienced medical or clinical professional looking for a high-impact role in a global organization, these new Amneal job openings are an excellent opportunity.
🔹 1. Manager – Medical Reviewer (Global Case Processing Operations)
Key Responsibilities
- Lead and mentor the global case processing team.
- Oversee ICSR processing, triage, and regulatory compliance.
- Perform medical review: seriousness, causality & expectedness.
- Ensure compliance with ICH, FDA, EMA regulations.
- Lead internal/external audits and inspection readiness.
- Manage CAPA, deviations, and QMS activities.
- Collaborate cross-functionally on complex safety cases.
- Prepare safety reports, KPIs, dashboards, and compliance metrics.
- Conduct training on PV processes, SOPs, and global reporting.
- Support risk management and medical information queries.
Required Skills
- Expertise in pharmacovigilance regulations (ICH/FDA/EMA).
- Advanced ICSR processing and safety database skills (Argus, ArisG, Veeva).
- Strong knowledge of MedDRA & WHO Drug coding.
- Thorough understanding of ALCOA+ principles.
- Audit readiness, CAPA, root cause analysis.
- Leadership & people management.
Qualification
- MBBS or Doctor of Pharmacy
- 8+ years in pharmacovigilance and 5+ years in a managerial role.
🔹 2. Deputy Manager / Manager – Clinical Trials Management
Key Responsibilities
- Review clinical trial protocols, ICFs, CRFs, logs & study documents.
- Evaluate CRO SIV presentations for regulatory compliance.
- Review eCRFs and edit checks on multiple EDC platforms.
- Accompany CRO teams for SIV and close-out visits.
- Track patient recruitment and ensure project timelines.
- Oversight of site monitoring and issue resolution.
- Manage CRO invoicing and milestone-based payments.
- Review PK and CEP study operations for USFDA, EU & Canada markets.
- Conduct scientific review of Clinical Study Reports (CSR).
Qualification
- M.Pharm (Clinical Pharmacy/Pharmacology)
- 5–7 years of experience in clinical trial operations.
⭐ Why Join Amneal?
- Work in a global pharmaceutical organization.
- Contribute to high-impact drug safety and clinical development.
- Exposure to regulated markets (USFDA, EMA, Health Canada).
- Opportunity for leadership and cross-functional collaboration.
- Growth-oriented and inclusive work culture.
📍 Job Location
Amneal Pharmaceuticals
2nd Floor, W-1, Behind Old Big Bazaar, Ahmedabad, Gujarat 380058, India
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📅 How to Apply
Application Link For Manager, Medical Reviewer | Global Case Processing Operations
Application Link For Deputy Manager / Manager – Clinical Trials management
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