Executive, Pharmacovigilance & Drug Safety

Amneal Pharmaceuticals

1 - 4 years

3 - 7 Lacs

Ahmedabad

Posted:1 month ago| Platform:

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Skills Required

Training Junior Staff Clinical operations MIS QMS Reconciliation Standard operating procedures Pharmacovigilance Regulatory affairs Drug safety

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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