Drug Safety Specialist

6 days ago


Midrand, Gauteng, South Africa Cipla Full time

We are looking for a highly motivated Drug Safety Specialist to join our team at Cipla. As a Drug Safety Specialist, you will be responsible for assisting the Drug Safety Manager in ensuring the Company's compliance with relevant laws, regulations, and guidelines governing drug safety.

You will collect and collate 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.
Additional Accountabilities

Understand signal management processes and conduct signal detection activities.

Serve as Regulatory Intelligence specialist for the PV function.

Comply with PVA/SDEA requirements.



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