Requirements: English
Company: PharmaLex
Region: Cagliari , Sardinia
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.