Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We seek a strong PV Specialist who is ready for an oversight role.
Main Responsibilities:

Set up and manage the local pharmacovigilance system
Conduct local literature searches
Manage local ICSR processes
Perform PV intelligence screening
Maintain the local PSMF
Set up local organized data collection
Manage local PVA
Adapt and submit PSUR/RMP locally
Detect signals locally
Implement additional risk minimization measures
Review materials related to local post-authorization safety
Participate in PV audits and inspections
Attend project meetings as scheduled
Provide monthly PV status reports
Ensure PV training for affiliates, service providers, and third parties
Collaborate closely with global PV systems and related departments
Maintain and review pharmacovigilance procedures
Support the Deputy in PV activities and provide relevant updates
Take on additional tasks in 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 are required. Knowledge of relevant legislative and non-legislative PV guidelines is essential.
Minimum Skills, Knowledge, and Abilities:

Proven leadership, mentoring, and staff management skills
Ability to train and support junior colleagues
Experience managing small projects
Ability to manage operational relationships at various levels
Excellent communication skills (written and verbal)
Ability to communicate issues and propose solutions to decision-makers
Good presentation skills
Fluent in English and Italian

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