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 who is ready for 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. Set up 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 status reports
15. Ensure PV training for affiliates, service providers, and third parties
16. Collaborate closely with global PV systems and related departments
17. Maintain and review pharmacovigilance procedures
18. Support the Deputy in PV activities and provide relevant updates
19. Take on additional tasks in project management and client communication as needed

Education and Experience:

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 PV guidelines is essential.

Minimum Skills, Knowledge, and Abilities:

• Proven leadership, mentoring, and staff management skills
• Ability to train and support junior colleagues
• Experience managing small projects
• Ability to manage operational relationships at various levels
• Excellent communication skills (written and verbal)
• Ability to communicate issues and propose solutions to decision-makers
• Good presentation skills
• Fluent in English and Italian