Senior Director (m/f/d) DSE Pharmacovigilance Operations (PVOps)

<p></p> <p> </p> <h2><b>Passion for Innovation. Compassion for Patients. </b></h2> <p> </p> <p>With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.</p> <p>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.</p> <p>In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.</p> <p>Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.</p> <p> </p> <p><b> </b></p> <p><b> </b></p> <p><span>For our Daiichi Sankyo European Headquarters (in Munich), we are looking for a</span></p> <p> </p> <h2><span>Senior Director (m/f/d) DSE Pharmacovigilance Operations (PVOps)</span></h2> <p> </p> <h2><span>The Position:</span></h2> <ul> <li><span>Leads the PV Operations team at DSE which is responsible for the oversight and management of individual case safety reports from pre- and post-marketing sources. This role ensures the appropriate collection and onward processing of safety reports in full compliance with external (regulatory) guidelines and internal standards. This role is responsible to develop and drive the strategy for the PV Operations function at the Regional and Global level, as applicable, and to promote internal process compliance, excellence and efficiency, incorporating proposals for process improvement and redesign. The position reports into the Executive Director PV Systems and Operations for DSE and the Global PV Operations Sub-Function Leads for ICSR/CRO Management and Clinical Study Start-up (CSS), respectively.</span></li> <li><span>The role requires close collaboration with the PV Systems sub-functions: Database Management and Analytics (DMBA), Partner and Affiliate Management (PAM) and PV Quality Management (PVQM) to ensure appropriate collection of safety information in the global safety database, collection of safety information at the local affiliate level, oversight of case processing by the CRO and meeting of internal and external compliance targets for case reporting and quality.</span></li> </ul> <p> </p> <h2><span>Roles and Responsibilities:</span></h2> <ul> <li><span>Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation and reporting of ICSRs for the DSE region. This includes ensuring ICSR report intake, case processing, workflow monitoring, follow-up requests, query management, ICSR quality control, reporting, adverse event reconciliation, partner reconciliation and case processing vendor oversight are conducted in accordance with internal KPIs and external regulatory guidelines. Ensures that non-conformances related to ICSR/CRO management are managed via the Reason of Delay (ROD) process in conjunction with PVQM. In the Global Sub-function structure, may assume overall responsibility for oversight of the PV Operations Standards Team, providing direction and support to the Global Sub-group Leads. The Standards Team is responsible for the two focus areas of (i) Documents, focusing on PV Operations standard operating procedures, data entry manuals, study associated documentation (e,g., adverse event flow plans) and review of PV Agreements for PV Operations aspects; and (ii) Processes, including CAPA management, preparation of training materials and providing project support for key transformational initiatives.</span></li> <li><span>Oversees the operational set up of safety data collection from DSE pre- and post-marketing clinical activities, including clinical studies, Managed Access Programmes, Patient Support Programmes and other organized data collection sources, such as market research, and ensures all adverse event collection is maintained in compliance with regulatory requirements. Facilitates and ensures communication with the sub-functions involved in the design and set up of clinical activities, including review of the protocol or study observational plan, development of the adverse event/serious adverse event flow plan, database configuration, development of eCRF, eDC, and adverse event/serious adverse event reconciliation process. Ensures the appropriate input to revision of procedural documents describing the management of clinical activities. Ensures regional alignment with the Global CSS strategy and contributes to the fulfillment of Global CSS objectives.</span></li> <li><span>This position is expected to be a key contributor/driver of process improvements to continue to meet regulatory demands and enhance efficiency through process excellen