Pharmalex is growing! As a result, we are looking for a PV Manager in Italy to lead projects. We are looking for a strong PV Specialist who is looking for a step up into an oversight role.
Main responsibilities:
Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures
Reviewing materials relating to local post-authorization safety
Participate in PV-relevant audits and inspections
Attend regular meetings according to project meeting schedule
Provide monthly PV report on status of local PV system in the country/ies
Ensure PV training of affiliate employees, service providers and Third Parties
Close cooperation with the global PV system of the client as well as related global and local departments and functions
Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
Deputy is assuming responsibility in case of planned or unplanned absence
The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required
Education and experience required
University degree in Life Science is desirable but not essential
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance
Minimum Skills, Knowledge and Ability Requirements
Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads).
Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
Good communication skills (written and verbally); capability to communicate issues and propose appropriate solutions to decision makers. Good presentation skills.
English business fluent & Italian.