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Senior Safety Specialist

1 week ago

Pretoria, Gauteng, South Africa Iqvia Argentina Full time
Job Description

This Senior Safety Specialist role plays a critical part in ensuring the medical safety of assigned local products in compliance with PSPV policies and regulations.

  • Provide subject matter expertise on pharmacovigilance systems and regulations.
  • Collaborate with cross-functional teams to develop and implement risk minimization measures.
  • Lead local PV activities in accordance with global, regional, and local regulations.

The ideal candidate will have advanced healthcare discipline degree or equivalent qualification and at least 5 years of experience in pharmacovigilance.

Key Responsibilities
  1. Replaces the Country Safety Head in most tasks when he/she is out of the office, including acting as local PV contact for authorities and being accountable for PV inspections.
  2. Supports the CSH in ensuring that local PV activities are performed in compliance with PSPV policies, as well as global, regional and local PV regulations.
  3. Operates as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head.
  4. Serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation.
  5. Maintain robust collaboration with in-country partner functions to carry out and monitor local PV activities.
  6. Secure with Medical Information, Clinical Study Unit, Quality and Marketing and local third party (e.g., CRO, vendors) the detection and transmission to PV unit of incoming PV data in a timely manner.
  7. Contribute to the development of local implementation plan of additional Risk Minimization Measures (aRMMs).
  8. Identify issues or dysfunction in the assigned country(ies) and escalate to CSH.
  9. Interact closely with Regions Governance Team.
  10. Ensure that education and training on PV and relevant safety topics within the local organization are performed.
  11. Manage local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions / Preventive Actions (CAPAs) implementation.
  12. Warrant inspection readiness of the local PV system.
  13. Monitor continuously incoming communication to ensure the detection and appropriate management of incoming PV data.
  14. Handle appropriately local periodic safety reports and contribute to the planning for PSRs.
  15. Ensure appropriate screening of local scientific/medical literature and process the relevant abstract/articles accordingly.
  16. Participate in the local business continuity plan and after hours' emergency calls process.
  17. Support the GSO with local safety surveillance activities.