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 (Individual Case Safety Reports)
4. Perform PV intelligence screening
5. Maintain the local PSMF (Pharmacovigilance System Master File)
6. Establish local organized data collection
7. Manage local PVA (Pharmacovigilance Activities)
8. Adapt and submit PSUR (Periodic Safety Update Reports) and RMP (Risk Management Plans)
9. Detect signals locally
10. Implement additional risk minimization measures
11. Review materials related to local post-authorization safety
12. Participate in PV-relevant audits and inspections
13. Attend regular project meetings
14. Provide monthly PV reports on the local PV system status
15. Ensure PV training for affiliate employees, service providers, and third parties
16. Collaborate closely with the global PV system and related departments
17. Develop, review, and maintain pharmacovigilance procedures
18. Support the Deputy in PV activities and provide relevant updates
19. Take on additional tasks and project management activities 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. Expertise in relevant legislative and non-legislative PV guidelines is also necessary.

Skills, Knowledge, and Abilities:

• Proven leadership, mentoring, and management skills
• Ability to train and support junior colleagues
• Experience managing small projects with defined scope
• Ability to manage operational relationships with internal teams and clients
• Excellent communication skills, both written and verbal
• Strong presentation skills
• Fluent in English and Italian