Associate Director - Clinical Surveillance
Eli Lilly
- Cork
- Permanent
- Full-time
- Lead, motivate and work with team members to establish appropriate performance objectives in alignment with GPS organization goals and employee’s development plan.
- Assure team members understand the scientific objectives and the importance of his/her role.
- Ensure optimal resource and workload management.
- Ensure a coordinated and consistent approach to scientific issues, removal of barriers and staff management across teams, functions and sites.
- Assure appropriate training and qualifications of staff and participate in succession planning to meet business needs and achieve objectives.
- Influence and contribute to Global Patient Safety (GPS) strategy.
- Ensure the ongoing development and optimization of core competencies for assigned work deliverables
- Oversee the implementation of assigned work deliverables (i.e. periodic safety reports, risk minimization plans, post authorization safety studies) ensuring compliance with global requirements and with demonstrated efficiency and productivity.
- Build collaborative working relationships with internal GPS functions (i.e. Medical, Pharmacoepidemiology and Safety Management, Reporting, and Data Sciences) to ensure appropriate capabilities are focused on the support of risk management activities for Lilly products, including clinical development and post-launch safety-related activities.
- Maintain current knowledge of pharmacovigilance and relevant standard operating procedures and policies, global regulations, etc.
- Apply judgment based decision making principles to ensure execution of deliverables with speed and quality
- Ensure the quality of assigned work deliverables and practical application of global procedures and tools.
- Ensure organizational consistency and compliance with processes and procedures.
- Ensure appropriate metrics and systems are in place to monitor quality and compliance activities.
- Maintain compliance with assigned curriculum maps.
- Lead or contribute to business process improvement initiatives.
- Continually seek and implement means of improving processes to reduce cycle time and decrease work effort.
- Support the implementation of the flexible sourcing strategy by effectively partnering with the management team, GPS staff, and vendor staff.
- Provide safety surveillance scientific expertise to GPS-external customers (e.g., Regulatory, Affiliates, Medicines Development Unit, Business Units, Discovery and Clinical Research, Alliance Partners) to fulfill safety obligations, achieve outcomes and promote effective pharmacovigilance planning.
- Represent Lilly in relevant external pharmacovigilance forums.
- Understand the role and responsibilities of the EU QPPV.
- Ensure applicable support of the EU QPPV to fulfill his/her legal responsibilities.
- Bachelor’s degree or equivalent work experience, in healthcare or scientific field
- Demonstrated project management and time management skills
- Demonstrated ability to work effectively cross-culturally and in a virtual work environment
- Demonstrated ability to work independently and as a team member to manage complex initiatives across functions.
- Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships
- Strong knowledge of regulations and guidelines that apply to patient safety regulatory obligations
- Excellent attention to detail