Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We are seeking a strong PV Specialist looking 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 ICSRs
4. Perform PV intelligence screening
5. Maintain the local PSMF
6. Establish local organized data collection
7. Manage local PV activities
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 regularly
14. Provide monthly PV status reports
15. Ensure PV training for staff and third parties
16. Coordinate with global PV systems and local departments
17. Maintain pharmacovigilance procedures
18. Support deputy in PV activities and provide updates
19. Take on additional tasks as needed, including project management and client liaison
Education and Experience
University degree in Life Sciences is desirable but not essential. Several years of experience and profound knowledge in pharmacovigilance, including familiarity with relevant legislation and guidelines.
Skills, Knowledge, and Abilities
* Leadership, mentoring, and team management skills
* Ability to train and support junior staff
* Project management skills for small projects
* Operational relationship management skills
* Excellent communication skills, both written and verbal
* Proficiency in English and Italian (business fluent)
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