Pharmacovigilance Manager

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

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a PV Manager in Italy. This role involves overseeing pharmacovigilance processes, managing local systems, training staff, and ensuring compliance with regulatory standards. Candidates should possess strong project management skills and experience in the field. Fluency in English and Italian is essential.

Competenze

• Several years of experience in pharmacovigilance required.
• Profound knowledge of legislative and non-legislative guidelines.
• Ability to train and support junior colleagues.

Mansioni

• Manage local pharmacovigilance system and processes.
• Conduct literature searches and manage ICSR.
• Provide monthly PV reports and ensure training.

Conoscenze

Leadership

Communication

Project Management

Operational Relationship Management

Mentoring

Formazione

University degree in Life Sciences (desirable)

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 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 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 Audit) processes
8. Adapt and submit PSUR (Periodic Safety Update Report) / RMP (Risk Management Plan) 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 reports on the status of the local PV system
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 and provide relevant PV activity 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, along with expertise regarding relevant legislative and non-legislative guidelines.

Skills, Knowledge, and Abilities

• Proven leadership, mentoring, and management skills
• Ability to train and support junior colleagues
• Experience in managing small projects
• Strong operational relationship management skills
• Excellent communication skills, both written and verbal
• Ability to communicate issues and propose solutions to decision-makers
• Good presentation skills
• Fluent in English and Italian