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 processes
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 affiliates, service providers, and third parties
16. Coordinate closely with the global PV system and related departments
17. Maintain and review pharmacovigilance procedures
18. Support the Deputy in PV activities and replace them during absences
19. Take on additional tasks as needed, including project management and client contact roles

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. Knowledge of relevant legislative and non-legislative guidelines is essential.

Skills, Knowledge, and Abilities:

• Proven leadership, mentoring, and management skills
• Ability to train and support junior colleagues
• Experience managing small projects
• Ability to manage internal and external relationships
• Excellent communication skills (written and verbal)
• Ability to communicate issues and propose solutions effectively
• Good presentation skills
• Fluent in English and Italian