PV Manager
Descrizione dell'offerta
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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:
- Set up and manage the local pharmacovigilance system
- Conduct local literature searches
- Manage local ICSR processes
- Maintain local PSMF
- Establish and oversee 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 project meetings regularly
- Provide monthly PV status reports
- Ensure PV training for affiliate employees and third parties
- Collaborate with global PV systems and related departments
- Maintain pharmacovigilance procedures
- Coordinate with the Deputy and support PV activities
- Take over additional tasks as needed, including project management and client communication
Education and Experience:
- University degree in Life Science (desirable but not essential)
- Several years of PV experience with strong knowledge of relevant guidelines
Skills and Knowledge:
- Leadership, mentoring, and staff management skills
- Ability to train and support colleagues and manage small projects
- Operational relationship management skills
- Excellent communication and presentation skills