For our Global Safety and Pharmacovigilance department, we are looking for a

DACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)

R-248154

Fulltime / permanent/ non-tariff

The DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety Officer(s) within the designated cluster. This position provides expert input on pharmacovigilance-related matters and develops strategy for the assigned cluster, ensuring PV processes are completed seamlessly in support of the organization's long-term vision and goals. Acts as the primary point of contact for Safety Officers (SOs) in the respective cluster and work closely with the Regional Head of Europe, IPV to manage regional PV activities, operational issues & risks, projects and ultimately optimize the cohesiveness of the region. This role will maintain relationships with General Managers of this cluster.

• Provides strategic leadership and guidance to Pharmacovigilance (PV) team members, as well as the wider organisation, to ensure the delivery PV activities in alignment with the requisite quality and compliance standards.
• Directly manages and develops the PV team in the assigned region, setting clear performance expectations and providing regular feedback. Fosters a collaborative and high-performance culture within the team, encouraging innovation and continuous improvement. Conducts performance reviews, identifies development needs, and implements development plans to enhance team capabilities.
• Ensure adequate resourcing and succession planning within the PV team to meet current and future business needs.
• Support Regional Head of Europe in development and implementation of a comprehensive PV strategy for the region, ensuring alignment with local and global regulatory requirements and corporate objectives. Ensures that the license to operate is maintained. Acts as a primary point of contact for all PV-related matters in their region, and timely communication and escalation of PV-relevant issues as per established global processes.
• Accountable for consistent implementation of GVP compliant processes, global standards and regulatory requirements in collaboration with interfacing functions within the cluster.
• Oversees the assessment, communication, and implementation of new or updated PV requirements in the region. Provides strategic advice to management and directs and reviews updates to controlled documents and platforms to align with evolving regulations
• Leverages a diverse and robust set of sources including but not limited to regulatory intelligence, continuous improvement initiatives, key performance indicators (KPIs) as well as audit/inspection findings, to direct enhancements to local PV systems. Oversees SO compliance against available KPIs and follows up in case of non-compliance. Supports SOs with compliance improvement activities and escalates issues and trends to key stakeholders in IPV as needed.
• Oversee/support IPV projects and improvement initiatives, as delegated by the Head of Europe, International Pharmacovigilance.
• Establishes good working relationships with GSPV, Global Regulatory Affairs (GRA), regional counterparts and local stakeholders, such as Local Quality Officer (e.g., for PTCs), Marketing and Medical Affairs (e.g., for ODCSs) etc. Partakes in internal meetings regarding product safety, as needed.
• Responsible for effective stakeholder management and communication with key departments (ComOps, GRA, R&DQA etc...). Establishes and maintains strong partnerships with CSL's enterprise commercial functions to enhance the performance of local PV activities, assess impact on resource, budget and managed services
• Participates in local/regional Commercial Operations Leadership Team meetings as required and provides input to strategic planning discussions as needed, ensuring alignment of PV activities with broader organizational objectives.
• Serves as PV Subject Matter Expert for local PV inspections by Regulatory Authorities in collaboration with LSOs, CSL QPPV, GSPV IPV, PVRQA, and relevant functions. Oversees and provides support to SOs in the preparation of audit / inspection, and in compliment to the IPV Audit, Inpsection & Performance Optimisation (AIPO) strategy. Provides strategy and input on close-out activities including the development of CAPA plans and close out of action items. Ensures all commitments in the region are completed in a timely manner.
• Serves as the SO in resident/designated country, as required.

• Bachelor's degree / Diploma (e.g. in the biological, nursing, healthcare or pharmaceutical sciences, quality or economics) or equivalent
• 9+ years experience in the Pharmaceutical or Biotech industry, in accordance with applicable local pharmacovigilance legislation
• Demonstrated ability to lead diverse teams and deliver results.
• Knowlege of international standards and regulatory requirements/regulations related to pharmacovigilance
• Excellent written and verbal communication skills in English required
• Fluency in one or more languages of the region would be a plus

• Travel Requirements: domestic and international, up to 15% of the year

• Excellent income potential and extended benefits
• Two additional leave days for your personal wellbeing
• Family services such as psychological support, legal advice, family care services and more for you and your direct family
• Hybrid working models