Executive, Pharmacovigilance & Drug Safety

1 - 4 years

3 - 7 Lacs

Posted:1 month ago| Platform: Naukri logo

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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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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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