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
- Lead, mentor, and manage the global case processing and medical review team, driving a culture of accuracy, compliance, and operational excellence.
- Perform medical review of adverse event reports for seriousness, causality, expectedness, and benefit-risk assessment.
- Oversee end-to-end ICSR processing workflow to ensure 100% regulatory timeline compliance (FDA, EMA, Health Canada, PMDA, etc.).
- Conduct regular performance reviews, provide constructive feedback, and support career development of team members.
- Lead preparation and participation in internal and external audits/inspections (USFDA, EMA, MHRA, WHO, etc.).
- Drive CAPA implementation arising from audits, deviations, or quality events using root cause analysis tools (5-Why, Fishbone, FMEA).
- Monitor KPIs such as case timeliness, quality metrics, backlog status, and submission compliance.
- Author, review, and approve SOPs, work instructions, templates, and training materials.
- Deliver comprehensive training programs on medical assessment, coding, narrative writing, and regulatory reporting.
- Provide medical input into responses to regulatory authority queries and medical information requests (MIRF).
- Identify process improvement opportunities using Lean/Six Sigma principles and implement best-in-class practices.
- Ensure strict adherence to ALCOA+ data integrity principles across all safety data processes.
- Collaborate with Quality Assurance, Regulatory Affairs, Medical Affairs, and Global Safety teams on risk management and signal detection activities.
- Stay updated with evolving global PV regulations (ICH E2B(R3), EU GVP modules, FDA FAERS, etc.) and cascade changes to the team.
- 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)
- Update your resume clearly highlighting:
– Years of PV experience
– Years in managerial role
– Safety database experience (Argus/ArisG/Veeva)
– Medical review & audit facing experience - Visit the official Amneal Careers portal: https://jobs.amneal.com
- Search for the position using keywords:
“Manager Medical Reviewer” OR “Global Case Processing” OR “Ahmedabad” - Click on the relevant job listing and hit “Apply Now”
- Register/Login and complete the online application form
- Upload your updated resume and any supporting documents
- 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
For verified pharma job updates, visit PharmaJobHub.in – India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
