This position primarily serves as Deputy Local Safety Officer (LSO) for our Spanish and Italian Affiliates and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV systems are operating appropriately by executing operational PV tasks.
Act as the Deputy of the National PV Contact Persons in Spain and Italy.
This position will act as a back-up for the LSOs to support their implementation of the DSE PV policy strategy, assuring the local PV system is operating appropriately by overseeing and executing operational PV tasks in Spain and Italy.
The individual will be accountable for liaising with other DSES and DSIT stakeholders (e.g. Regulatory, Medical Affairs, Marketing) as well as local PV vendors, and providing PV Training to the relevant local functions and external parties as necessary to ensure PV processes are implemented properly.
This position will report to the Local Safety Officer in Spain and is expected to work independently with minimal guidance with specialized knowledge, and use expertise to analyze and solve problems.
Roles and Responsibilities Act as back-up of the primary contact point/nominated person for pharmacovigilance for the Spanish and Italian Health Authorities. Responsible for supporting the LSOs in performing/overseeing all local PV activities in Spain and Italy. Supports the LSOs in ensuring safety report collection process is implemented and oversees the processes are working properly. Involved in creating and updating local procedures in line with regulatory requirements and European PV processes. Responsible for acting as contact person for pharmacists, physicians, and consumers for the reporting of adverse events (AEs) and Product Technical Complaints (PTCs) to collect safety information and their follow-up activities. Performs/oversees local literature screening, monitoring of local PV legislation, and implementation of Risk Management Plans (RMPs) and additional Risk Minimization Measures at a local level as required. Liaises with local stakeholders (e.g. Medical, Marketing) as well as local PV vendors, and providing PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly (e.g. Market Research Programs). Contributes to the maintenance of the EU Pharmacovigilance System Master File (PSMF) by providing up-to-date information from the local PV system. Contributes to the company's benefit-risk evaluation for Daiichi Sankyo products and to answering requests from Competent Authorities. Acts as a key contributor for the GVP affiliate audits/inspections in Spain and Italy. PV process enhancement: Contributes to the enhancement of EU affiliates PV Quality Management System standards by providing the inputs from local PV Systems. Facilitates the local implementation of global processes (e.g. management of the collection of adverse events, PV regulatory intelligence, management of Safety Data Exchange Agreements). Vendor/Partner oversight: Implements/maintains PV agreements/SDEAs with local partners/PV service providers working with internal subject matter experts (SMEs) ensuring all PV requirements are covered in the contract. Maintain contract template as current. Coordinates periodic communications with partners and ensure the contract is up-to-date and the process is operating well (e.g. PV service providers, Market research vendors) and ensure periodic reconciliations are carried out. Oversees the activities of the PV vendor support. Skills and Additional Requirements 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. Possesses 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. Willingness to travel. Flexible and adaptable. Why work with us? Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
For more information: www.daiichi-sankyo.es
#J-18808-Ljbffr
