Senior Director, PV Operations Lead Europe (m/f/d)

Senior Director, PV Operations Lead Europe (m/f/d)

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

For our headquarters in Munich we are seeking highly qualified candidates to fill the position:

Roles and Responsibilities

• Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation, and reporting of ICSR 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;
  • (ii) Processes, including CAPA management, preparation of training materials, and providing project support for key transformational initiatives.

Further Roles and Responsibilities

• This role may assume responsibility for leading specific teams within Global PV Operations, leading in a matrix setting with team representatives across all regional sites, ensuring global and regional tasks assigned to the specific sub‐group are met in accordance with global objectives, with a focus on continuous improvement and driving process excellence and efficiency gains.
• This position will have overall line management responsibility for the DSE PV Operations Team, participating in hiring, compensation, and personnel management decisions.
• In addition, this position may be responsible for matrix management across regions in accordance with the Global PV Operations infrastructure and initiatives.

Education & Experience

• Education:
  • Medical doctor, pharmacist, or Bachelor’s degree, preferably in healthcare or life sciences.
• Experience:
  • Sufficient expertise in local, European, and international regulatory and pharmacovigilance requirements.
  • Profound work experience in pharmacovigilance, including both investigational and marketed products, and comprising solid management experience.

Skills and Additional Requirements

• Practices situational leadership; is able to assess the skills and development needs of the team and adjust style of management/leadership accordingly.
• Actively promotes individual growth and further development.
• Develops performance expectations and supervises others within the function; actively develops and implements changes to improve processes within the function.
• Develops and executes complex functional strategic plans; effectively prioritizes tasks in accordance with strategy and provides guidance to others within the regional and/or global functions (as applicable).
• Possesses an expert ability to independently identify issues and thoroughly understands the causes of those issues; recognizes the functional impact; can balance risks; provides suggestions for resolution and implements the solution.
• Provides effective leadership and serves as a subject matter expert throughout the function; possesses expert knowledge and experience to influence PV operational processes.
• Communicates effectively within the functional teams, regionally and globally.
• Ensures the team consistently executes internal and external deliverables on time.
• Leverages pharmacovigilance knowledge to promote operational excellence, efficiency/effectiveness, and compliance; shares expertise within the function.
• Excellent English skills.