Roles and Responsibilities

• 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.

Roles and Responsibilities

• 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.
• This position is expected to be a key contributor/driver of process improvements to continue to meet regulatory demands and enhance efficiency through process excellence.
• This includes the identification of areas for improvement and ensuring the successful implementation of changes to processes in accordance with global strategy.
• This role is also responsible for developing and tracking implementation of corrective/preventive actions related to PV Operations findings from compliance monitoring, non-conformance management, quality events, audits, and inspections.
• The Lead drives appropriate communication and escalation of compliance-related issues within CSPV, including leadership/QPPV and other relevant stakeholders, for continuous improvement.
• Effectively manages the DSE PV Operations Team leaders to ensure that all ICSR handling and clinical study start-up activities remain fully compliant with regulatory requirements and aligned with global standards.
• Is responsible for ensuring the adequate resourcing of the team to fulfill its obligations, and other general aspects of line management, including hiring, compensation, and personnel management decisions.

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.