Pv Manager

Buscojobs; Abruzzo; 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 to oversee pharmacovigilance projects. The ideal candidate will manage local systems, conduct literature searches, and ensure compliance with safety regulations. Strong leadership and communication skills are essential for this role, along with a background in pharmacovigilance. This position offers the opportunity to collaborate with global teams and contribute significantly to patient safety initiatives.

Competenze

• Several years of experience in pharmacovigilance required.
• Familiarity with legislative and non-legislative guidelines.

Mansioni

• Manage the local pharmacovigilance system.
• Conduct local literature searches and signal detection.
• Provide monthly PV reports on local system status.

Conoscenze

Leadership

Communication

Problem Solving

Project Management

Formazione

University degree in Life Sciences

Descrizione del lavoro

Pharmalex PV Manager - Italy

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 ICSR (Individual Case Safety Reports)
4. Perform PV intelligence screening
5. Maintain local PSMF (Pharmacovigilance System Master File)
6. Establish local organized data collection
7. Manage local PVA (Periodic Safety Update Report) activities
8. Adapt and submit PSUR/RMP (Periodic Safety Update Report / Risk Management Plan)
9. Conduct local signal detection
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 local PV system status
15. Ensure PV training for affiliate employees, service providers, and third parties
16. Collaborate closely with the global PV system and related departments
17. Issue, review, and maintain pharmacovigilance procedures in accordance with client guidelines
18. Support the Deputy in PV activities and assume responsibilities during their absence
19. Take on additional tasks related to project management and client communication as needed

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 legislative and non-legislative guidelines, are required.

Skills, Knowledge, and Abilities

• Proven leadership, mentoring, and staff management skills
• Ability to train and support junior colleagues
• Experience managing small projects with defined scope
• Strong operational relationship management skills with internal and external stakeholders
• Excellent communication skills (written and verbal) and problem-solving abilities
• Good presentation skills
• Fluent in English and Italian