Pharmacovigilance Manager

JR Italy; Mantova; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in the healthcare sector is looking for a PV Manager in Italy to oversee projects and manage the local pharmacovigilance system. The successful candidate will be responsible for a range of activities including literature searches, training staff, and ensuring compliance with safety regulations. Candidates should have several years of experience in pharmacovigilance and strong leadership skills.

Competenze

• Several years of pharmacovigilance experience required.
• Knowledge of relevant PV guidelines preferred.

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

Mentoring

Staff management

Communication

Presentation

Formazione

University degree in Life Sciences

Descrizione del lavoro

Social network you want to login/join with:

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 ready to step into an oversight role.

Main responsibilities:

• Set up and manage the local pharmacovigilance system
• Conduct local literature searches
• Manage local ICSR processes
• Maintain the local PSMF
• Establish local organized data collection
• Manage local PVA activities
• Adapt and submit PSUR / RMP locally
• Implement additional risk minimization measures
• Review materials related to local post-authorization safety
• Participate in PV audits and inspections
• Attend regular project meetings
• Provide monthly PV status reports
• Ensure PV training for affiliates, service providers, and third parties
• Collaborate closely with the global PV system and related departments
• Maintain pharmacovigilance procedures (SOPs, working practices)
• Coordinate with the Deputy and inform about PV activities
• Assume responsibilities during Deputy's absence
• Take on additional tasks in other service lines and project management as needed

Education and experience required

• University degree in Life Sciences preferred but not essential
• Several years of pharmacovigilance experience
• Knowledge of relevant legislative and non-legislative PV guidelines

Minimum Skills, Knowledge and Ability Requirements

• Leadership, mentoring, and staff management skills
• Ability to train and support junior colleagues and lead small projects
• Operational relationship management with clients and internal teams
• Excellent communication and presentation skills