Pharmacovigilance Manager

PharmaLex; Caserta; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

PharmaLex is expanding and seeks a PV Manager in Italy to lead pharmacovigilance projects. The role involves establishing local systems, managing compliance activities, and providing training. A strong background in pharmacovigilance and the ability to lead and mentor teams are essential for success in this oversight position.

Competenze

• Several years of experience in pharmacovigilance.
• Proficient in relevant legislative guidelines.
• Strong communication skills in English and Italian.

Mansioni

• Manage the local pharmacovigilance system.
• Conduct local literature searches and manage local ICSRs.
• Ensure PV training for staff and local data collection.

Conoscenze

Leadership

Communication

Team Management

Project Management

Formazione

University degree in Life Sciences

Descrizione del lavoro

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 who is looking for a step up 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 PVA 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 as scheduled
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 PV procedures and SOPs
18. Support the Deputy in PV activities and assume responsibilities during their absence
19. Take on additional tasks related to project management and client interactions 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, along with expertise in relevant legislative guidelines.

Skills and Knowledge:

Proven ability to lead, mentor, and motivate teams; capable of training junior staff; experienced in managing small projects. Strong communication skills in English and Italian, both written and verbal, and good presentation skills are essential. Ability to manage relationships at operational and leadership levels is required.