System Management Senior Specialist (m/f/x)

at  Daiichi Sankyo Europe

PASSION FOR INNOVATION. COMPASSION FOR PATIENTS.

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.
For our headquarters in all Europe we are seeking highly qualified candidates to fill the position:

PROFESSIONAL EXPERIENCE AND PERSONAL SKILLS:

• Professional experience & education
• Either Bachelor or Masters-level education in a relevant discipline, or at least five years’ experience in systems management or a related discipline.
• Understanding of Pharmacovigilance regulations (EU, ICH) and awareness of differing regulatory requirements in other regions.
• Understanding of overall design and structure of Argus Safety or similar PV database system.
• Knowledge of Argus Safety or similar PV database reporting configuration.
• Understanding of E2B ICSR structure.
• Personal skills
• Good English language skills, both written and verbal.
• Accuracy, reliability and attention to detail.
• Ability to work independently and without supervision on complex requests.
• Ability to work in cross-regional team including colleagues from different working cultures.
• Ability to work in inter-disciplinary teams.
• Ability to work under time-pressure.
• Experience with full Microsoft Office suite, particularly Excel and Powerpoint.
• Good presentation skills.

• Routinely conduct in-depth maintenance and oversight of the Argus Safety Database, in conjunction with Daiichi Sankyo database vendor.
• In-depth oversight, maintenance and enhancement of ICSR reporting configuration for EU/EEA Authorities and DSE-responsible Business Partners.
• Advanced support to CSPV and CRO Users, including detailed training and guidance on use of the database.
• Initiation, tracking and validation of Change Controls for Argus Safety database.
• Liaison with Daiichi Sankyo database vendor, CSPV Operations Team and Global Case Processing vendor on advanced and new configuration aspects.
• Creation of SOPs, and development/performance of OQ and PQ testing documentation.
• Advanced trouble-shooting of report scheduling, E2B ICSR transmission and import, and general user issues with the Argus Safety database.
• Input to database management activities and upgrade projects as required, including SME contributions to major projects impacting database management, and membership of global working groups or relevant workstreams during other CSPV systems projects.
• Flexibility for face to face meetings on site when required.