Job Description

Job Description

Job Responsibilities:  

1. Lead and mentor the global case processing team, fostering a collaborative and high-performance culture.
2. Oversee daily operations, ensuring timely and accurate processing of adverse event reports.
3. Conduct regular performance evaluations and provide feedback to team members.
4. Manage the intake and triage of adverse event reports, ensuring compliance with internal and external regulatory requirements.
5. Evaluate adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness.
6. Collaborate with cross-functional teams to resolve complex cases and support risk assessment activities.
7. Ensure adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards.
8. Develop and implement corrective and preventive action (CAPA) plans in response to audit findings, inspections and internal deviations.
9. Lead internal and external audits, preparing teams for inspections and ensuring readiness.
10. Identify opportunities for process optimization and implement best practices in case processing.
11. Monitor key performance indicators (KPIs) and prepare reports for management on case processing metrics and compliance activities.
12. Stay current with industry trends and regulatory changes, adjusting processes accordingly.
13. Develop training materials and conduct training sessions for staff on pharmacovigilance procedures and regulatory compliance.
14. Foster a culture of continuous learning and professional development within the team.
15. Provides inputs into responses to Medical inquiries from regulatory authorities or health care professionals on safety issues coming from MIRF (Medical Information Request Form).
16. Support the development and revision of Standard Operating Procedures (SOPs), work instructions, templates, and training guidance materials.
17. Lead and facilitate comprehensive training for all ICSR Processing team and ensuring adherence to best practices and regulatory standards.
18. 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

Qualifications

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.

About Us

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.

About the Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key roles that the Human Resources team performs:

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.