Executive, Pharmacovigilance & Drug Safety
Amneal Pharmaceuticals
Date: 14 hours ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
B. Pharma
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.
- Daily case intake (including AEs, MIs, PQCs) from Case Intake System into the Quality Management System, PV systems and triaging of all inbox cases, determine validity and seriousness.
- Perform reconciliation of cases with vendors and other interfaces to ensure all cases are captured and no cases are missed during the process.
- Collaborate with cross-functional teams, including medical affairs, regulatory affairs, and clinical operations, to gather necessary information for report completion and follow-up.
- Participate in training sessions to enhance understanding and implementation of safety regulation procedures and continuous update knowledge on pharmacovigilance practices to support team objectives.
- Partner with cross-functional stakeholders in the development, review and execution of SOP and supportive documents related to ICSR business processes.
- Assist in the development and maintenance of standard operating procedures (SOPs) related to intake and triage processes.
- Participate in training and mentoring of junior staff, providing guidance on intake processes and best practices.
- Support audits and inspections by maintaining comprehensive documentation and providing necessary reports and information.
B. Pharma
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.
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