Deputy Local Safety Officer
hace 3 días
This role serves as the Deputy Local Safety Officer for our Spanish and Italian Affiliates, ensuring compliance with pharmacovigilance regulatory requirements globally and locally. The successful candidate will oversee the local pharmacovigilance system, executing operational tasks and acting as the Deputy of the National PV Contact Persons in Spain and Italy.
Key Responsibilities:- Act as the Deputy of the National PV Contact Persons in Spain and Italy.
- Oversee the local pharmacovigilance system, ensuring it operates appropriately.
- Liaise with other DSES and DSIT stakeholders, as well as local PV vendors.
- Provide PV Training to relevant local functions and external parties.
- Support the LSOs in performing/overseeing all local PV activities in Spain and Italy.
- Responsible for creating and updating local procedures in line with regulatory requirements and European PV processes.
- Act as the contact person for pharmacists, physicians, and consumers for the reporting of adverse events and Product Technical Complaints.
- Perform/oversee local literature screening, monitoring of local PV legislation, and implementation of Risk Management Plans and additional Risk Minimization Measures at a local level.
- Previous experience in Pharmacovigilance activities in the Spanish PV affiliate, experience within Italy is advantageous.
- Bachelor's degree in Life Sciences, Pharmacy or Medical Sciences with post graduate qualification preferred.
- Strong knowledge of International, European and local PV laws and guidance.
- Considerable pharma organisation awareness (interrelationship of departments, business priorities, including significant experience working cross-functionally).
- A focus on accuracy and integrity.
- Analytic and systematic approach with good problem-solving skills.
- Ability to understand complex matters with a continuous focus on improvement.
- Strong communication skills and an ability to work with respect and appreciation of cultural diversity.
- Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams.
- Fluency in Spanish, English and Italian is a mandatory requirement.
- 2 to 5 years of experience in a similar role required.
Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to improving the lives of patients through innovative treatments. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
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