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Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We are seeking a strong PV Specialist looking to step into an oversight role.
Main responsibilities:
1. Set up and manage the local pharmacovigilance system
2. Conduct local literature searches
3. Manage local ICSR processes
4. Maintain the local PSMF
5. Establish local organized data collection
6. Manage local PVA
7. Adapt and submit PSUR / RMP locally
8. Implement additional risk minimization measures
9. Review materials related to local post-authorization safety
10. Participate in PV audits and inspections
11. Attend regular project meetings
12. Provide monthly PV status reports for the local PV system
13. Ensure PV training for affiliate employees, service providers, and third parties
14. Collaborate closely with the global PV system and related departments
15. Develop and maintain pharmacovigilance procedures aligned with client standards
16. Coordinate with the Deputy and inform them of PV activities
17. Act as Deputy during absences
18. Be willing to take on additional tasks related to other service lines and project management as needed
Education and experience required:
* University degree in Life Sciences is preferred but not mandatory
* Several years of pharmacovigilance experience and expertise
* Knowledge of relevant legislative and non-legislative PV guidelines
Minimum skills, knowledge, and abilities:
* Proven leadership, mentoring, and management skills
* Ability to train and support junior colleagues and lead small projects
* Strong operational relationship management skills
* Excellent communication skills (written and verbal), with the ability to present and propose solutions effectively
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