Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We are seeking a strong PV Specialist ready to advance into 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
* Establish local organized data collection systems
* Manage local PVA activities
* Adapt and submit PSUR / RMP locally
* Conduct local signal detection
* 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 for the local PV system
* Ensure PV training for affiliate employees, service providers, and third parties
* Collaborate closely with the global PV system and related departments
* Issue, review, and maintain pharmacovigilance procedures
* Coordinate with the Deputy and provide updates on PV activities
* Assume responsibility during Deputy's absence
* Perform additional tasks related to other service lines and project management as needed
Education and experience required
* A university degree in Life Sciences is preferred but not mandatory
* Several years of experience and in-depth knowledge in pharmacovigilance
* Expertise in relevant legislative and non-legislative PV guidelines
Minimum skills, knowledge, and abilities
* Proven leadership, mentorship, and management skills
* Ability to train and support junior colleagues and lead small projects
* Strong operational relationship management skills with internal and external stakeholders
* Excellent communication skills, both written and verbal; capable of presenting solutions to decision-makers
* Fluent in English and Italian
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