Deputy Pharmacovigilance Cluster Lead - BeNeLux - 70000048

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada., 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.

Ihre Aufgaben

This position will act as the back-up for the Pharmacovigilance Cluster Lead, supporting the execution of the DSE CSPV policy strategy across the BeNeLux region. This role ensures compliance with global and local pharmacovigilance (PV) regulatory requirements and oversees the proper functioning of the local PV Systems by managing and performing operational PV tasks in the designated countries under the leadership of the DSE PV EU Affiliate Management Team.The individual will be accountable for liaising with other DSBE and DSNL 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 Pharmacovigilance Cluster Lead in BeNeLux and is expected to work mainly independently with minimal guidance with specialized knowledge and use expertise to analyze and solve problems., In this position you will act as back-up of the primary contact point/nominated person for pharmacovigilance for the Health Authorities in Belgium, Luxembourg, and the Netherlands. You will be responsible for supporting the Pharmacovigilance Cluster Lead in performing/overseeing all local PV activities in the BeNeLux region. You will support the Pharmacovigilance Cluster Lead 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 and global 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.

• 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.

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  PV process improvement:

• Contributes to the enhancement of EU affiliates PV Quality Management System standards by providing the inputs from local PV system.

• Facilitate local implementation of global processes (e.g., management of the collection of adverse events, PV regulatory intelligence, management of Safety Data Exchange Agreements).

  PV Licensee/Supplier Supervisor

  Together with the Cluster Lead works on the implementation/maintenance of 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 ensures 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.

Ihr Profil

• Bachelor's degree in Life Sciences, Pharmacy or Medical Sciences with post graduate qualification preferred.,

• Previous experience in Pharmacovigilance activities in the BeNeLux region.

• Possesses strong knowledge of International, European and local PV laws and guidance.

• Native speaker of one of the official local languages in the cluster countries and fluent in the other local languages (i.e., French, Flemish, Dutch); proficient in English.

Skills and additional Requirements

• Strong 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.

• Flexible and adaptable.

Kontakt

For more information: www.daiichi-sankyo.nl