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 employees, service providers, and third parties
16. Coordinate with global PV systems and related departments
17. Maintain pharmacovigilance procedures in line with client standards
18. Support the Deputy and inform on PV activities
19. Take on additional tasks related to project management and client contact 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.

Skills, Knowledge, and Abilities:

• Proven leadership, mentoring, and management skills
• Ability to train and support junior colleagues
• Experience managing small projects
• Strong relationship management skills at operational and client levels
• Excellent communication skills, both written and verbal
• Ability to communicate issues and propose solutions to decision-makers
• Good presentation skills
• Fluent in English and Italian