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Regulatory Affairs Expert

1 week ago

Pretoria, Gauteng, South Africa Iqvia Argentina Full time

As Regulatory Affairs Expert, you will be responsible for ensuring compliance with global, regional, and local PV regulations.

The ideal candidate will have experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products.

Main Responsibilities:

  1. Ensuring local PV activities are performed in compliance with PSPV policies and global, regional, and local PV regulations
  2. Managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head
  3. Supporting the CSH in ensuring local PV activities are performed in compliance with PSPV policies and global, regional, and local PV regulations
  4. Maintaining robust collaboration with in-country partner functions to carry out and monitor local PV activities
  5. Securing detection and transmission of incoming PV data from various sources in a timely manner
  6. Contributing to the development of local implementation plans for additional Risk Minimization Measures (aRMMs)
  7. Identifying issues or dysfunction in assigned countries and escalating to CSH
  8. Interacting closely with the Regions Governance Team
  9. Ensuring education and training on PV and relevant safety topics within the local organization
  10. Managing local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation
  11. Ensuring inspection readiness of the local PV system
  12. Monitoring continuously incoming communication for the detection and appropriate management of incoming PV data
  13. Handling local periodic safety reports and contributing to the planning for PSRs
  14. Ensuring screening of local scientific/medical literature and processing relevant abstracts/articles accordingly
  15. Participating in the local business continuity plan and after-hours emergency calls process
  16. Supporting the GSO with local safety surveillance activities