Pharmacovigilance Manager

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

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a PV Manager to lead pharmacovigilance projects in Italy. The role involves managing local PV systems, conducting audits, and ensuring compliance with relevant regulations. The ideal candidate will have extensive experience in pharmacovigilance, with strong leadership abilities and excellent communication skills.

Competenze

• Several years of experience in pharmacovigilance.
• Proven leadership and management skills.
• Ability to manage relationships at all levels.

Mansioni

• Set up and manage the local pharmacovigilance system.
• Provide monthly PV reports on the local PV system status.
• Ensure PV training for affiliate employees and service providers.

Conoscenze

Leadership

Mentoring

Communication

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
• Maintain 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-relevant audits and inspections
• Attend regular project meetings
• Provide monthly PV reports on the local PV system status
• Ensure PV training for affiliate employees, service providers, and third parties
• Collaborate closely with the global PV system and related departments
• Maintain pharmacovigilance procedures (SOPs, Working Practices) related to local tasks
• Coordinate with the Deputy and provide updates on PV activities
• Assume responsibilities during Deputy's absence
• Take on additional tasks as required, including project management and client contact roles

Education and experience required

• University degree in Life Science is desirable but not essential
• 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 management skills
• Ability to train and support junior colleagues and lead small projects
• Ability to manage internal and external relationships at operational and leadership levels
• Excellent communication skills (written and verbal); capable of presenting and proposing solutions effectively