Reporting to the Chief Development Officer, the VP, Drug Safety & Pharmacovigilance will be responsible for leading the overall strategic direction for Safety and Pharmacovigilance and, through leadership of the team, oversee the operational delivery of safety and pharmacovigilance activities at Bicycle.You will be a highly experienced and visionary member of the Development Leadership Team and will actively contribute to the broader clinical development strategy.Key responsibilitiesDevelop and implement a comprehensive drug safety & pharmacovigilance strategy aligned with Bicycle’s overall mission and goalsCollaborate with senior executives to integrate drug safety & pharmacovigilance considerations into overall business strategies, clinical development plans and broader decision-making processesManage and lead the patient safety and pharmacovigilance function including oversight for activities, operations, and continued evolution toward a best-in-class organizationAccountable for ensuring that appropriate resources, systems and processes are in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all programsProvide expert guidance and decision-making and will help to shape the strategy and direction of the global function to meet the organizational needs and contribute toward the overall R&D strategyWork with key stakeholders within the organization to develop safety and PV strategy for current products under development including proactively identifying and communicating emerging potential and/or urgent safety issues and to support signal detection and risk/benefit evaluation.Provide oversight of Serious Adverse Event (SAE) processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP).Maintain expert knowledge of current ICH and health authority requirements, expectations, and trends in patient safety and pharmacovigilance, and ensure compliance in all activities. Ensure readiness for health authority inspections and partner audits, and represent Spark in inspections, audits, and other health authority meetings as required.Design, direct, and conduct ongoing safety surveillance of company drug products using internal and external resources to ensure delivery of high-quality pharmacovigilance services.Ensure risk management/reduction strategies are developed and included in relevant documents such as clinical study protocols.Represent Bicycle in interactions with regulatory agencies, industry consortia, and external stakeholders on drug safety mattersMonitor industry best practices and changes in global safety regulations and guidelines.Provide direction and leadership for departmental policies, SOPs, systems, communications, reporting e.g., DSUR, PSUR, periodic line listings) and vendor selection/management to ensure global regulatory compliance.
