Amneal Pharma Hiring for Manager / Medical Reviewer

Amneal Pharma Hiring for Manager / Medical Reviewer | 8+ Yrs PV Experience | Ahmedabad | MBBS/PharmD Required

Are you an experienced pharmacovigilance professional with strong medical assessment skills and proven leadership experience? Amneal Pharmaceuticals, a fast-growing global generic and specialty pharmaceutical company, is hiring a Manager – Medical Reviewer for its Global Case Processing Operations team based in Ahmedabad, Gujarat, India. This is a high-impact leadership role ideal for MBBS or PharmD professionals with 8+ years in pharmacovigilance and at least 5 years in people management. Amneal Pharma Hiring for Manager / Medical Reviewer

This is a Hot Job – high priority opening with excellent growth potential within one of India’s leading USFDA-approved pharmaceutical companies. Amneal Pharma Hiring for Manager / Medical Reviewer

Job Highlights Box

Position: Manager – Medical Reviewer (Global Case Processing)
Location: Ahmedabad City, Gujarat, India (On-site)
Qualification: MBBS or Doctor of Pharmacy (PharmD)
Experience: Minimum 8 years in Pharmacovigilance | Minimum 5 years in Managerial/Leadership role
Department: Global Drug Safety & Pharmacovigilance
Key Expertise Required: ICSR Processing, Medical Assessment, Argus/ArisG/Veeva Vault, MedDRA Coding, Audit & Inspection Readiness
Job Nature: Full-Time | Individual Contributor + People Management
Company: Amneal Pharmaceuticals India Pvt Ltd

About Amneal Pharmaceuticals

Amneal is a diversified global pharmaceutical company with a strong presence in the United States, India, and Europe. Known for its high-quality generic, biosimilar, and specialty branded products, Amneal operates multiple USFDA, MHRA, and EU-approved manufacturing facilities. The company is committed to affordable medicine and patient safety through robust pharmacovigilance systems. Amneal Pharma Hiring for Manager / Medical Reviewer

Amneal is an equal opportunity employer that celebrates diversity and fosters an inclusive work culture.

Detailed Job Responsibilities

As Manager – Medical Reviewer, you will lead medical oversight of global individual case safety reports (ICSRs) while managing a high-performing case processing team. Key responsibilities include: Amneal Pharma Hiring for Manager / Medical Reviewer

1. Lead, mentor, and manage the global case processing and medical review team, driving a culture of accuracy, compliance, and operational excellence.
2. Perform medical review of adverse event reports for seriousness, causality, expectedness, and benefit-risk assessment.
3. Oversee end-to-end ICSR processing workflow to ensure 100% regulatory timeline compliance (FDA, EMA, Health Canada, PMDA, etc.).
4. Conduct regular performance reviews, provide constructive feedback, and support career development of team members.
5. Lead preparation and participation in internal and external audits/inspections (USFDA, EMA, MHRA, WHO, etc.).
6. Drive CAPA implementation arising from audits, deviations, or quality events using root cause analysis tools (5-Why, Fishbone, FMEA).
7. Monitor KPIs such as case timeliness, quality metrics, backlog status, and submission compliance.
8. Author, review, and approve SOPs, work instructions, templates, and training materials.
9. Deliver comprehensive training programs on medical assessment, coding, narrative writing, and regulatory reporting.
10. Provide medical input into responses to regulatory authority queries and medical information requests (MIRF).
11. Identify process improvement opportunities using Lean/Six Sigma principles and implement best-in-class practices.
12. Ensure strict adherence to ALCOA+ data integrity principles across all safety data processes.
13. Collaborate with Quality Assurance, Regulatory Affairs, Medical Affairs, and Global Safety teams on risk management and signal detection activities.
14. Stay updated with evolving global PV regulations (ICH E2B(R3), EU GVP modules, FDA FAERS, etc.) and cascade changes to the team.
15. Support ad-hoc pharmacovigilance projects as assigned by the Department Head.

Required Skills & Expertise (Must-Have)

• Pharmacovigilance Regulations (ICH, FDA, EMA, GVP) – Advanced
• ICSR Processing & Global Submission Rules – Advanced
• Medical Assessment (Causality, Seriousness, Expectedness) – Intermediate to Advanced
• MedDRA & WHO-Drug Coding – Advanced
• Safety Databases: Oracle Argus, ArisG, or Veeva Vault Safety – Advanced
• Quality Management Systems (QMS), Deviation Management, CAPA – Advanced
• Audit & Inspection Facing Experience – Expert level preferred
• SOP Authoring & Training Delivery – Advanced
• Risk Management (ICH Q9) & Operational Excellence – Advanced
• People Leadership & Team Management – Advanced

Amneal Pharma Hiring for Manager / Medical Reviewer

Essential Qualifications & Experience

• MBBS (Bachelor of Medicine & Bachelor of Surgery) OR Doctor of Pharmacy (PharmD) from a recognized university
• Minimum 8 years of hands-on pharmacovigilance experience
• Minimum 5 years in a managerial or team lead role within drug safety/PV operations
• Prior experience in medical review of ICSRs is mandatory
• Proven track record of facing regulatory inspections (USFDA/EMA/MHRA) strongly preferred
• Excellent command over written and spoken English
• Strong analytical thinking and decision-making skills

Why Join Amneal’s Pharmacovigilance Team?

• Work with one of the fastest-growing generic pharmaceutical companies globally
• Direct exposure to global regulatory submissions and inspections
• Clear career progression path into Senior Manager / Associate Director roles
• Competitive salary and performance-linked incentives
• Comprehensive health insurance and wellness programs
• Collaborative and inclusive work environment
• Continuous learning and global exposure

Work Culture & Equal Opportunity

Amneal proudly promotes diversity, equity, and inclusion. We do not discriminate based on caste, religion, gender, disability, sexual orientation, or any other protected characteristic. We believe in merit-based growth and equal opportunities for all. Amneal Pharma Hiring for Manager / Medical Reviewer

How to Apply (Step-by-Step)

1. Update your resume clearly highlighting:
   – Years of PV experience
   – Years in managerial role
   – Safety database experience (Argus/ArisG/Veeva)
   – Medical review & audit facing experience
2. Visit the official Amneal Careers portal: https://jobs.amneal.com
3. Search for the position using keywords:
   “Manager Medical Reviewer” OR “Global Case Processing” OR “Ahmedabad”
4. Click on the relevant job listing and hit “Apply Now”
5. Register/Login and complete the online application form
6. Upload your updated resume and any supporting documents
7. Submit your application

Note: Applications via email, LinkedIn, or third-party consultants will NOT be accepted. Only applications submitted through the official Amneal careers portal will be considered. Amneal Pharma Hiring for Manager / Medical Reviewer

Pro Tip: Mention your total PV experience and leadership tenure prominently in the first page of your resume to pass initial screening. Amneal Pharma Hiring for Manager / Medical Reviewer

Don’t miss this career-defining opportunity to lead medical review operations at a globally respected pharmaceutical company. Amneal Pharma Hiring for Manager / Medical Reviewer

Application Link

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