Regional, Pharmacovigilance and Product Quality Assurance

JOB DESCRIPTION

1. PV and Product QA management and compliance.

2. PV and Product QA vendor managements

3. Ownership of compiling, reviewing and implementing PV and Product QA related compliance SOPs and contracts (global, regional and local).

4. Audit and process review management both internally and externally including partners and each competent authority 

5. Communication system management including safety inbox for each territory.

6. Environmental monitoring including local and global literature search support and liaising with global colleagues on reporting.

7. Creation, Monitoring and updating of Risk Management Plans and Specific Annex in each territory, as required.

8. PV Training for employees (Regionally), including monitoring and PV training reports for all territories

9. Pharmacovigilance regulations monitoring, impact assessment and actions for each territory.

10. Submission of Aggregate reports for each territory (including PSUR), where applicable

11. Product safety monitoring (NPP, marketed product/ IIT/ Medical Inquiry) and reporting for each territory (where applicable)

12. Monthly PV and QA Reconciliation reports for each territory

13. Support with recall and mock recall for each country

     

DESIRED QUALIFICATIONS

1. Tertiary education: medical, pharmacy, science or equivalent.

2. Experience with the implementation and management of PV and Product QA systems.

3. Strong understanding of local, regional and global PV and Product QA standards across the pharmaceutical industry.

4. Collaborative, resilient with strong interpersonal skills