FIND_THE_RIGHTJOB.
Manager, Medical Reviewer | Global Case Processing Operations
JOB_REQUIREMENTS
Hires in
Not specified
Employment Type
Not specified
Company Location
Not specified
Salary
Not specified
Job Responsibilities:
- Lead and mentor the global case processing team, fostering a collaborative and high-performance culture.
- Oversee daily operations, ensuring timely and accurate processing of adverse event reports.
- Conduct regular performance evaluations and provide feedback to team members.
- Manage the intake and triage of adverse event reports, ensuring compliance with internal and external regulatory requirements.
- Evaluate adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness.
- Collaborate with cross-functional teams to resolve complex cases and support risk assessment activities.
- Ensure adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards.
- Develop and implement corrective and preventive action (CAPA) plans in response to audit findings, inspections and internal deviations.
- Lead internal and external audits, preparing teams for inspections and ensuring readiness.
- Identify opportunities for process optimization and implement best practices in case processing.
- Monitor key performance indicators (KPIs) and prepare reports for management on case processing metrics and compliance activities.
- Stay current with industry trends and regulatory changes, adjusting processes accordingly.
- Develop training materials and conduct training sessions for staff on pharmacovigilance procedures and regulatory compliance.
- Foster a culture of continuous learning and professional development within the team.
- Provides inputs into responses to Medical inquiries from regulatory authorities or health care professionals on safety issues coming from MIRF (Medical Information Request Form).
- Support the development and revision of Standard Operating Procedures (SOPs), work instructions, templates, and training guidance materials.
- Lead and facilitate comprehensive training for all ICSR Processing team and ensuring adherence to best practices and regulatory standards.
- Ad Hoc Activities: Provides comprehensive support for pharmacovigilance-related projects and activities, as delegated by the Department Head/ Designee, to ensure operational efficiency and compliance.
Required Skills:
- Pharmacovigilance Regulations (ICH, FDA, EMA) – Advanced
- Individual Case Safety Report (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
- Compliance Monitoring & Controls – Advanced
- Risk Management (ICH Q9 principles) – Advanced
- Operational Excellence - Advanced
- Leadership and People Management - Advanced
M.B.B.S (Bachelor of medicine and Bachelor of Surgery) or Doctor of Pharmacy
Minimum of 8 years of experience in pharmacovigilance, with at least 5 years in a managerial role.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Similar jobs
Senior Manager, Patient Safety Scientist
Bristol Myers Squibb
India
6 days ago
Safety & PV Specialist I
Syneos Health
India
6 days ago
Freelance Peer Reviewer - Obstetrics, Gynecology, and Reproductive Medicine
Cactus Communications
Delhi, India
6 days ago
Associate Director, Patient Safety Scientist
Bristol Myers Squibb
India
6 days ago
Adjudication Specialist
Connect and Heal
India
6 days ago
Pharmacovigilance Services Sr Analyst
Accenture
India
11 days ago
Manager, Medical Reviewer | Global Case Processing Operations
Amneal Pharmaceuticals
Ahmedabad, India
11 days ago
© 2025 Qureos. All rights reserved.