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 ready 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 cases
4. Perform PV intelligence screening
5. Maintain the local PSMF
6. Establish local organized data collection
7. Manage local PVA activities
8. Adapt and submit PSUR/RMP locally
9. Detect signals locally
10. Implement additional risk minimization measures
11. Review materials related to local post-authorization safety
12. Participate in PV audits and inspections
13. Attend project meetings as scheduled
14. Provide monthly PV status reports
15. Ensure PV training for staff and third parties
16. Collaborate closely with global PV systems and local departments
17. Maintain pharmacovigilance procedures
18. Support the Deputy in PV activities and assume responsibilities during their absence
19. Take on additional tasks related to project management and client communication as needed
Education and Experience:
A university degree in Life Sciences is desirable but not essential. Several years of experience and profound knowledge in pharmacovigilance are required, along with expertise in relevant legislative guidelines.
Skills, Knowledge, and Abilities:
* Leadership, mentoring, and team management skills
* Ability to train and support junior colleagues
* Experience managing small projects
* Operational relationship management skills
* Excellent communication skills (written and verbal)
* Proficiency in English and Italian
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