Manager, Medical Reviewer – Global Case Processing Operations
Location: Ahmedabad, Gujarat, India
Category: Pharmacovigilance & Drug Safety
Experience Required: Minimum 8 years in pharmacovigilance, including 5 years in managerial roles
Job ID: 6902
Application Deadline: 13/12/2025
Job Overview
Amneal is seeking a Manager, Medical Reviewer to lead and mentor our global case processing team in Ahmedabad. This role is critical for ensuring the timely, accurate, and compliant processing of Individual Case Safety Reports (ICSRs) while fostering a culture of operational excellence, regulatory adherence, and continuous professional development.
The ideal candidate will have a strong background in pharmacovigilance regulations, ICSR processing, and medical review, combined with proven leadership experience in a global operations environment.
Key Responsibilities
Lead, mentor, and manage the global case processing team, fostering a high-performance and collaborative culture.
Oversee daily ICSR operations, ensuring compliance with internal SOPs and external regulatory requirements (ICH, FDA, EMA).
Conduct performance evaluations, provide constructive feedback, and support team development.
Review and triage adverse event reports, evaluating seriousness, causality, expectedness, and quality of documentation.
Collaborate with cross-functional teams to resolve complex cases and support risk assessment and benefit-risk evaluations.
Develop, implement, and monitor Corrective and Preventive Action (CAPA) plans following audits, inspections, or internal deviations.
Lead internal and external audits and inspection readiness activities, ensuring team compliance and preparedness.
Identify opportunities for process optimization and operational efficiency in global case processing.
Monitor KPIs, prepare compliance and performance reports for management, and ensure data integrity using ALCOA+ principles.
Support the creation and revision of SOPs, work instructions, templates, and training materials.
Provide guidance on responses to medical inquiries from regulatory authorities or healthcare professionals via Medical Information Request Forms (MIRF).
Conduct comprehensive training sessions for ICSR processing teams to ensure adherence to best practices and regulatory standards.
Support ad hoc pharmacovigilance projects as delegated by the Department Head.
Required Skills & Competencies
Pharmacovigilance Regulations: ICH, FDA, EMA – Advanced
ICSR Processing: Advanced
Medical Assessment & Benefit-Risk Thinking: Intermediate
Coding Standards: MedDRA, WHO Drug – Advanced
Safety Database Management: Argus, ArisG, Veeva Vault Safety – Advanced
Global Reporting Requirements: Advanced
Data Integrity & ALCOA+ Principles: Advanced
SOPs/WIs/Templates Authoring: Advanced
Quality Management & CAPA (Root Cause Analysis, FMEA): Advanced
Audit & Inspection Readiness: Expert
Deviation Management & QMS: Advanced
Risk Management (ICH Q9 principles): Advanced
Operational Excellence: Advanced
Leadership and People Management: Advanced
Qualifications
M.B.B.S. (Bachelor of Medicine and Bachelor of Surgery) or Doctor of Pharmacy (PharmD).
Minimum 8 years of experience in pharmacovigilance, including at least 5 years in a managerial or supervisory role.
Proven expertise in ICSR review, medical assessment, and regulatory compliance.
Strong leadership, communication, and interpersonal skills for managing global teams.
In-depth knowledge of pharmacovigilance guidelines, data integrity, quality management systems, and audit readiness.
Work Environment & Additional Information
Full-time position based at Ahmedabad, Gujarat.
Opportunities for global cross-functional collaboration.
Ability to influence and drive continuous improvement in global pharmacovigilance operations.
Commitment to diversity, equity, and inclusion, with equal opportunity employment.
About Amneal:
Amneal is a global pharmaceutical company committed to delivering high-quality medicines and innovative therapies. We foster a collaborative, inclusive work environment, empowering employees to drive scientific excellence, operational efficiency, and patient safety.
Learn more: www.amneal.com
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