Senior Manager, Data Management

PharmaLex; Rimini; In loco; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

PharmaLex is looking for a PV Manager in Italy, tasked with setting up and managing the local pharmacovigilance system. The role involves leading various aspects of pharmacovigilance, ensuring compliance with guidelines, and training staff. This position is ideal for those with extensive experience in pharmacovigilance who are ready to take a leadership step.

Competenze

• Several years’ experience and profound knowledge in pharmacovigilance.
• Expertise regarding relevant legislative and non-legislative guidelines.
• Demonstrable ability in leading and managing staff.

Mansioni

• Set up and manage the local pharmacovigilance system.
• Provide monthly PV report on status of local PV system.
• Ensure PV training of affiliate employees and service providers.

Conoscenze

Leadership

Mentoring

Communication

Formazione

University degree in Life Science

Descrizione del lavoro

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 seeking a step up into an oversight role.

Main responsibilities :

1. Set up and manage the local pharmacovigilance system
2. Local Literature Search
3. Local ICSR Management
4. Local PSMF Maintenance
5. Setting up local Organized Data Collection
6. Local PVA Management
7. Local adaptation and submission of PSUR / RMP
8. Implementation of additional Risk Minimization Measures
9. Reviewing materials relating to local post-authorization safety
10. Participate in PV-relevant audits and inspections
11. Attend regular meetings according to project meeting schedule
12. Provide monthly PV report on status of local PV system in the country/ies
13. Ensure PV training of affiliate employees, service providers, and Third Parties
14. Close cooperation with the global PV system of the client as well as related global and local departments and functions
15. Issue, review, and maintain pharmacovigilance procedures (e.g., Standard Operating Procedures, Working Practices) related to local tasks in connection with client procedures
16. Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
17. 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 motivating staff (team leads)
• Ability to train and support junior / new colleagues in daily activities; ability to lead small projects with a clearly defined scope
• Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as at the client's team lead level
• Good communication skills (written and verbal); capability to communicate issues and propose appropriate solutions to decision makers. Good presentation skills.