ABBOTT Laboratories Ltd.

Pharmacovigilance Liaison Manager- Philippines, Cambodia, Myanmar and Thailand

ABBOTT Laboratories Ltd.
Salary provided
Posted on 20 Jan 2021

Pharmacovigilance Liaison Manager- Philippines, Cambodia, Myanmar and Thailand

ABBOTT Laboratories Ltd.

Job Highlights

  • Based in Thailand
  • Provide Performance Bonus
  • Flexible working hour

Job Description

Core Job Responsibilities:
General Pharmacovigilance activities/Compliance:
  1. Ensure that PV requirements are performed at the local level. This includes Affiliate PV activities, the implementation of GPV policies and SOPs as applicable, implementation of Affiliate SOPs, PV training for all local staff (including sales representatives) and archiving of Affiliate PV documents.
  2. Ensure implementation of changes in GPV policies and SOPs in Affiliate SOPs as applicable within 60 days of global documents becoming effective.
  3. Regularly check the Affiliate Contact Lists on the GPV Teamsite and immediately inform Regional PV of any changes needed. Immediately inform all applicable License Partners concerning changes in the Affiliate PV staff.
  4. If required by local legislation, describe the Affiliate PV System (e.g. as DDPS, PSMF, PSSF etc., as applicable).
  5. Immediately inform the Regional PV Manager of any changes in the local PV regulations that might impact the global PV system.
  6. Keep the Local PV Requirements Inventory on the GPV Teamsite up to date and Immediately inform GPV on any changes in the local regulations that might affect the ICSR distribution.
  7. Immediately inform GPV for change in local products and about any new local contracts or license agreements which might require the exchange of safety data and Maintenance of (an) accurate local products list(s) to clearly show the product status as global or local.
  8. Immediately inform the GPV about any scheduled Audit or Inspection including business partner audits.
  9. Lead the PV audit/inspection process locally, with support from the relevant local or global functions.
  10. Train all Affiliate staff regarding “Basic PV” obligations.
  11. Upload all local PV Service Agreements in the Affiliate PV Service Agreements Inventory, on the GPV Teamsite
  12. Upload all locally prepared periodic safety reports in the Local PSUR Inventory on the GPV Teamsite.
  13. PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.
  14. Record retention (archiving). Ensures Pharmacovigilance documents are archived as per GPV policy
  15. Monitoring of Affiliate PV system performance and compliance, and resolving of nonconformities
  16. Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Abbott Global Pharmacovigilance (GPV), and of Individual Case Safety Reports (ICSRs) and Periodic Reports for submission to the Regulatory Authority.
  17. Reports monthly compliance metrics to Global Pharmacovigilance (GPV) within the required timelines
  18. Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies
  19. Informs Local regulatory affairs for label updates as per information received from GPV.


Minimum Experience/Training Required:
  1. PV/CRA/MIS related experience in pharmaceutical company are preferred
  2. Understand of local legislation regarding PV
  3. Familiarity of medical terminology and product information
  4. Good communication skills with internal and external stakeholders

Additional Information

Career Level
ผู้จัดการ / อาวุโส
Qualification
ปริญญาโท
Years of Experience
5 ปี
Job Type
งานเต็มเวลา

Company Overview

URGENTLY REQUIRED!!!

At Abbott, we’re committed to helping you live your best possible life through the power of health.  For more than 125 years, we’ve brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Additional Company Information