Job Description

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.