Sourcing Manager

4 weeks ago

Pretoria, Gauteng, South Africa Job Masters Pty Ltd Full time

Division: Medical Services and PV

Department: Medical Affairs

Employment Type: Permanent

Job Purpose: Assisting the Drug Safety Manager in ensuring that the Company is at all times compliant with the relevant laws, regulations, and guidelines that govern drug safety and for establishing and maintaining the drug safety system so that information regarding all suspected adverse reactions reported to Company employees is collected and collated to be accessible for an overall view.

In the absence of the Drug Safety Manager, assume the responsibilities of the DSM as the Deputy.

Accountabilities
  1. Pharmacovigilance (PV): Understand various functions of PV and operational aspects. Assist with day-to-day PV operational activities. Understand ICSRs (Individual Case Safety Reports) management and assessment as per internal procedures. Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR), and regulatory reporting (RR), in line with company SOPs. Ensure the maintenance of a high standard of care quality processing. Follow-Up on all AE / ADR related queries received from spontaneous / solicited reports within the timelines specified in company SOPs. Update RMP implementation tracking and compile safety sales data on request. Highlight any safety-related issues to the attention of the management team. Assist in conducting reconciliation of all adverse event reports received by PV from internal (QA / MI and ACC) and external stakeholders. Support with the preparation and implementation of PV SOPs. Assist in raising and closing out all CAPAs, Deviations, and Actions on time as per internal company SOPs.
  2. Understand SDEA obligations: Ensure all aspects under agreements are duly executed.
  3. Support the continuous development and improvement of the PV function while upholding Cipla core values.
  4. Understand signal management processes and conduct signal detection activities.
  5. Serve as Regulatory Intelligence specialist for the PV function.
  6. Comply with the requirements set out in the PVA / SDEA's.
  7. Identify and develop key relationships with Cipla global.
  8. Leverage compliance expertise and alignment with Global Drug Safety.
  9. Responding and assisting to ad hoc business requests.
  10. Undertake research on a variety of tasks and projects and present findings in a confident and professional manner.
  11. Complete Performance Reviews.
  12. Raise and review Change Controls for safety variations, etc.
  13. Assist in training all Cipla employees and distributors/service providers on Pharmacovigilance and act as the learning management system administrator for PV.
  14. Assist with review and compilation of SDEAs.
Education Qualification

Passed and Completed Tertiary Degree: Degree or Diploma in Health Sciences.

Relevant Work Experience

1-3 years in Pharmacovigilance or Medical Affairs.

Competencies / Skills

Collaborate to Succeed, Strong Domain Knowledge, Innovate to Excel, Lead with Empathy, Perform with Accountability, People Management, Act with Agility.

Employment Equity: Cipla is an Employment Equity employer, and this position will be filled based on our Employment Equity Plan.

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