IT- Local Safety Officer

at  Daiichi Sankyo Europe

This position primarily serves as a Local Safety Officer (LSO) for our Italian Affiliate and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV system is operating appropriately by executing operational PV tasks.
Act as the local National PV Contact Person in Italy.
This position is accountable for ensuring the implementation of the DSE PV policy strategy, assuring the local PV system is operating appropriately by overseeing and executing operational PV tasks in Italy.
The individual will be accountable for liaising with other 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 DSE PV Partner & Affiliate Manager and is expected to work independently with minimal guidance with specialized knowledge, and use expertise to analyze and solve problems.

SKILLS AND ADDITIONAL REQUIREMENTS

• Possesses strong knowledge of International, European, and local PV legislation and guidance
• Bachelor’s degree at the minimum required; 5 years of experience with an advanced degree; 8 years of experience with a bachelor’s degree (Experience as a local safety officer is preferred)
• Master’s degree in Life Sciences, Pharmacy, or Medical Sciences preferred
• Good or excellent written and verbal communication skills in English and Italian
• Analytic and systematic approach with good problem-solving skills
• Ability to understand complex matters with a continuous focus on improvement
• Substantial collaboration skills, in particular also on an intercultural level with respect and appreciation of cultural diversity
• Proactive, autonomous, and reliable working style paired with the ability to work in international matrix teams with accurate operating principles
• Flexible and adaptable

• Act as primary contact point/nominated person for pharmacovigilance for the Italian Health Authority.
• Responsible for performing/overseeing all local PV activities in Italy.
• Ensures safety report collection process is implemented and oversees the processes are working properly.
• Creates and updates 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.
• Be accountable for liaising 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 primary contact person for the affiliate audit/inspection in Italy.

PV process enhancement:

• Closely communicates with the European PV Affiliate Management team and Contributes to the enhancement of EU affiliate’s PV Quality Management System standards by providing 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:
• Implement/maintain 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.
• Coordinate 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).
• Oversees the activities of the PV vendor support.