Pharmacovigilance Manager

JR Italy; Bolzano; 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 role involves managing the local PV system, conducting literature searches, and training staff. Ideal candidates will have a background in Life Sciences and strong communication skills.

Competenze

• Several years of PV experience and expertise required.
• Strong communication skills, both written and verbal.
• Ability to train and support junior colleagues.

Mansioni

• Set up and manage the local pharmacovigilance system.
• Conduct local literature searches.
• Prepare monthly PV reports on the local PV system status.

Conoscenze

Leadership

Mentoring

Communication

Project Management

Formazione

University degree in Life Science

Descrizione del lavoro

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Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We are looking for a strong PV Specialist who is seeking a step up 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
• 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 reports on the local PV system status
• Ensure PV training for affiliate staff, service providers, and third parties
• Collaborate closely with the global PV system and related departments
• Issue, review, and maintain pharmacovigilance procedures
• Coordinate with the Deputy and provide updates on PV activities
• Assist the Deputy during absences
• Take on additional tasks related to project management and client communication, as appropriate

Education and experience required:

• University degree in Life Science is preferred but not mandatory
• Several years of PV experience and expertise
• Knowledge of relevant legislative and non-legislative PV guidelines

Minimum skills, knowledge, and abilities:

• Leadership, mentoring, and team management skills
• Ability to train and support junior colleagues; manage small projects
• Ability to manage operational relationships with clients and internal teams
• Strong communication skills, both written and verbal; good presentation skills