PV Manager

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Pharmalex PV Manager Role in Italy

Pharmalex is growing! We are seeking a PV Manager in Italy to lead projects and oversee pharmacovigilance activities. We are looking for 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. Maintain the local PSMF
5. Establish organized local data collection
6. Manage local PVA activities
7. Adapt and submit PSUR / RMP locally
8. Implement additional risk minimization measures
9. Review materials related to local post-authorization safety
10. Participate in PV audits and inspections
11. Attend regular project meetings
12. Provide monthly PV status reports
13. Ensure PV training for affiliate employees, service providers, and third parties
14. Collaborate with global PV system and related departments
15. Maintain pharmacovigilance procedures and SOPs
16. Coordinate with the Deputy and report on PV activities
17. Assist the Deputy during absences
18. Support additional tasks and project management activities as needed

Education and Experience:

• University degree in Life Science preferred but not essential
• Several years of pharmacovigilance experience
• Knowledge of relevant legislative and non-legislative PV guidelines

Skills, Knowledge, and Abilities:

• Leadership, mentoring, and staff management skills
• Ability to train and support colleagues; lead small projects
• Proficiency in managing internal and external relationships
• Strong communication and presentation skills