Manager, Medical Reviewer – Global Case Processing Operations
Location: Ahmedabad, Gujarat, India
Job Type: Full-Time
Experience Required: Minimum 8 Years (including 5+ Years in a Managerial PV Role)
Industry: Pharmacovigilance & Drug Safety
Employer: Amneal Pharmaceuticals
Position Overview
Amneal Pharmaceuticals is seeking an experienced Manager, Medical Reviewer to lead its Global Case Processing Operations team in Ahmedabad. This role focuses on overseeing the end-to-end management of adverse event case processing, ensuring global regulatory compliance, operational excellence, and continuous improvement. The position requires strong leadership, in-depth knowledge of pharmacovigilance regulations, and the ability to execute high-quality medical evaluations.
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Key Responsibilities
Leadership and Team Management
Lead, mentor, and develop a global team of case processing specialists.
Foster a high-performance culture focused on collaboration, accuracy, and compliance.
Conduct routine performance assessments and provide developmental feedback.
Case Processing Oversight
Oversee daily operations to ensure timely and accurate processing of Individual Case Safety Reports (ICSRs).
Manage intake, triage, and prioritization of adverse event reports from global sources.
Review case quality, ensuring completeness and regulatory alignment.
Make medical assessments on seriousness, causality, expectedness, and clinical relevance.
Regulatory Compliance and Quality
Ensure adherence to international pharmacovigilance regulations, including ICH, FDA, EMA, and country-specific guidelines.
Lead internal and external audits, ensuring team readiness and regulatory compliance.
Develop and implement CAPA plans based on inspection findings and quality deviations.
Support risk assessment and benefit–risk evaluation activities.
Cross-Functional Collaboration
Collaborate with internal stakeholders across Medical Affairs, Quality, Safety Operations, and Regulatory.
Provide scientific inputs to respond to medical or safety inquiries from regulatory health authorities or HCPs.
Lead updates and revisions of SOPs, work instructions, templates, and operational guidelines.
Training and Capability Building
Design and deliver comprehensive training for ICSR processing teams.
Promote a culture of continuous learning, regulatory awareness, and operational excellence.
Continuous Improvement
Identify opportunities to optimize case processing workflows and system efficiencies.
Monitor and report key performance indicators (KPIs) and compliance metrics to senior leadership.
Stay informed on global PV regulations, MedDRA/WHO Drug updates, and evolving industry expectations.
Ad Hoc Responsibilities
Support pharmacovigilance projects and initiatives as delegated by the Department Head or Designee.
Required Skills and Technical Expertise
Advanced knowledge of pharmacovigilance regulations (ICH, FDA, EMA).
Expertise in ICSR processing and medical case assessment.
Proficiency in MedDRA and WHO Drug coding standards.
Strong understanding of safety databases (Argus, ArisG, Veeva Vault Safety).
Expertise in GxP, data integrity (ALCOA+ principles), and global reporting requirements.
Demonstrated ability in CAPA management, root cause analysis, FMEA, and QMS compliance.
Proven audit readiness and inspection leadership capabilities.
Strong leadership, operational excellence, and decision-making skills.
Qualifications
M.B.B.S. (Bachelor of Medicine and Bachelor of Surgery) or Doctor of Pharmacy (PharmD) required.
Minimum 8 years of experience in Pharmacovigilance, with at least 5 years in a managerial or supervisory role.
About Amneal
Amneal Pharmaceuticals is an equal opportunity employer dedicated to promoting diversity and inclusion. The organization ensures fair hiring and employment practices regardless of race, religion, gender, disability, or any protected characteristic.
About the Human Resources Team
The HR team plays a strategic and operational role across the organization by:
Providing high-level guidance on workforce planning and talent management.
Ensuring compliance with legal and best-practice employment policies.
Supporting teams through learning, development, performance management, and employee engagement.
Advising leaders on employee relations, labor market trends, and organizational development.
Job Details
Job ID: 6902
Category: Pharmacovigilance & Drug Safety
Posting Date: 02 December 2025
Application Deadline: 13 December 2025
Location: 2nd Floor, W-1, Behind Old Big Bazaar, Ahmedabad, Gujarat, 380058, India
Schedule: Full-Time
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