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Pharmalex PV Manager Role in Italy
Pharmalex is growing! We are seeking a PV Manager in Italy to lead projects. This role is ideal for a strong PV Specialist looking to advance into an oversight position.
Main Responsibilities:
Establish and manage the local pharmacovigilance system
Conduct local literature searches
Manage local ICSR processes
Maintain the local PSMF
Set up 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 other departments
Issue, review, and maintain PV procedures
Coordinate with the Deputy and provide updates on PV activities
Assume responsibilities during Deputy's absence
Support other service lines and project management tasks as needed
Education and Experience Requirements:
University degree in Life Sciences is desirable but not mandatory
Several years of pharmacovigilance experience
Knowledge of relevant legislative and non-legislative PV guidelines
Minimum Skills and Abilities:
Proven leadership, mentoring, and team management skills
Ability to train and support junior colleagues and lead small projects
Skill in managing internal and external relationships
Excellent communication and presentation skills
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