Pharmacovigilance Manager

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

Descrizione del lavoro

A leading company in the pharmaceutical industry seeks a PV Manager in Italy. This role involves overseeing pharmacovigilance projects, managing the local system, conducting literature searches, and ensuring compliance with safety regulations. Proven leadership and experience in managing projects are key for this position.

Competenze

• Several years of experience in pharmacovigilance required.
• Profound knowledge of PV guidelines is essential.
• Fluent in English and Italian.

Mansioni

• Set up and manage the local pharmacovigilance system.
• Conduct local literature searches and manage local ICSRs.
• Implement additional risk minimization measures.

Conoscenze

Leadership

Communication

Project Management

Client Relationship Management

Training

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 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 ICSRs
4. Perform PV intelligence screening
5. Maintain the local PSMF
6. Establish local organized data collection
7. Manage local PV assessments
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-relevant audits and inspections
13. Attend regular project meetings
14. Provide monthly PV status reports
15. Ensure PV training for affiliates, service providers, and third parties
16. Coordinate with the global PV system and local departments
17. Maintain and review pharmacovigilance procedures
18. Support the Deputy in PV activities and provide relevant updates
19. Take on additional tasks as needed, including project management and client contact roles

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 and Abilities:

• Proven leadership, mentoring, and management skills
• Ability to train and support junior colleagues
• Experience managing small projects
• Ability to handle internal and client relationships effectively
• Excellent communication skills, both written and verbal
• Fluent in English and Italian