Pharmacovigilance Manager

Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We seek 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
4. Perform PV intelligence screening
5. Maintain the local PSMF
6. Establish local organized data collection
7. Manage local PVA
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 reports on the local PV system status
15. Ensure PV training for affiliate staff, service providers, and third parties
16. Coordinate with the global PV system and related departments
17. Maintain and review pharmacovigilance procedures
18. Collaborate with the Deputy and inform them of PV activities

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 staff management skills
• Ability to train and support colleagues
• Project management skills
• Operational relationship management
• Excellent communication skills (written and verbal) in English and Italian