Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We seek 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
Perform PV intelligence screening
Maintain the local PSMF
Establish 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 reports on the local PV system status
Ensure PV training for affiliate employees, service providers, and third parties
Coordinate with global PV systems and related departments
Maintain pharmacovigilance procedures in line with client standards
Support the Deputy and inform on PV activities
Take on additional tasks related to project management and client contact 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.
Skills, Knowledge, and Abilities:

Proven leadership, mentoring, and management skills
Ability to train and support junior colleagues
Experience managing small projects
Strong relationship management skills at operational and client levels
Excellent communication skills, both 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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