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Medical Safety Professional

1 week ago

Midrand, Gauteng, South Africa Cipla Full time

As a Medical Safety Professional at Cipla, you will play a vital role in ensuring the Company's compliance with relevant laws, regulations, and guidelines governing drug safety.

You will be responsible for collecting and collating information regarding all suspected adverse reactions reported to Company employees, providing an overall view of our drug safety system.

Key Responsibilities
  • Assist the Drug Safety Manager in operational activities related to Pharmacovigilance (PV).
  • Understand various functions of PV and operational aspects.
  • Act as case owner for assigned ICSRs to ensure accurate completion of data entry, data review, and regulatory reporting.
  • Maintain a high standard of care quality processing.
  • Follow up on all AE/ADR related queries received from spontaneous/solicited reports within company timelines.
  • Update RMP implementation tracking and compile safety sales data on request.
  • Highlight any safety-related issues to the management team.
Additional Accountabilities

Support the continuous development and improvement of the PV function while upholding Cipla core values.

Understand signal management processes and conduct signal detection activities.

Serve as Regulatory Intelligence specialist for the PV function.

Comply with PVA/SDEA requirements.

Identify and develop key relationships with Cipla global.

Leverage compliance expertise and alignment with Global Drug Safety.