PV Manager

JR Italy; Treviso; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is looking for a passionate PV Manager to lead pharmacovigilance projects in Italy. This role involves setting up and managing local systems, conducting literature searches, and ensuring compliance with safety regulations. You'll collaborate closely with global teams, providing training and support to junior colleagues while maintaining high standards of operational excellence. Join a dynamic environment where your expertise in pharmacovigilance will make a significant impact on patient safety and product integrity.

Competenze

• Several years of experience in pharmacovigilance.
• Proven leadership and mentoring skills.

Mansioni

• Set up and manage the local pharmacovigilance system.
• Conduct local literature searches and manage local ICSR processes.
• Ensure PV training for affiliates and service providers.

Conoscenze

Leadership Skills

Communication Skills

Operational Relationship Management

Pharmacovigilance Knowledge

Formazione

University Degree in Life Sciences

Descrizione del lavoro

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Pharmalex PV Manager Role in Italy

Pharmalex is growing! We are seeking a PV Manager in Italy to lead projects. We prefer 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 processes.
4. Maintain local PSMF.
5. Establish local organized data collection.
6. Manage local PVA.
7. Adapt and submit PSUR/RMP locally.
8. Implement additional risk minimization measures.
9. Review materials related to local post-authorization safety.
10. Participate in PV audits and inspections.
11. Attend regular project meetings.
12. Provide monthly PV status reports.
13. Ensure PV training for affiliates, service providers, and third parties.
14. Collaborate closely with the global PV system and related departments.
15. Maintain pharmacovigilance procedures in line with client standards.
16. Coordinate with the Deputy, providing updates on PV activities.
17. Assist the Deputy during absences.
18. Be willing to undertake additional tasks in other service lines or project management, as appropriate.

Education and Experience:

• A university degree in Life Sciences is desirable but not mandatory.
• Several years of experience and profound knowledge in pharmacovigilance.
• Expertise in relevant legislative and non-legislative PV guidelines.

Minimum Skills, Knowledge, and Abilities:

• Proven leadership, mentoring, and team management skills.
• Ability to train and support junior colleagues and manage small projects.
• Strong operational relationship management skills with internal teams and clients.
• Excellent communication skills, both written and verbal, with the ability to present and propose solutions effectively.