VP, Pharmacovigilance (US/UK)

Worldwide Clinical Trials ,
Nottingham, Nottinghamshire
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Job Description

Want to join an energetic, collaborative team that is valued and supported by company leadership and committed to safety excellence? Worldwide Clinical Trials is an Uncommon CRO small enough to care, but big enough to matter! Subjects' safety is central to all we do. Worldwide Clinical Trials is seeking a Vice President, Pharmacovigilance (PV). The VP, Pharmacovigilance will provide leadership to the global PV team. You can be based remotely in the US or the UK. The Vice President, Pharmacovigilance will provide strategic leadership and technical expertise to the Pharmacovigilance department. As the VP, Pharmacovigilance, you will establish the optimal operational framework for the department ensuring pharmacovigilance deliverables are completed to a high quality and within agreed timelines. The VP, Pharmacovigilance will work with appropriate individuals to facilitate the development of the department and systems to plan for regulatory and industry changes . KEY DELIVERABLES: * Leadership of the Global Department, focusing on Quality Deliverables, Regulatory Timelines, Financial Results and Efficiency of Process * Managing and supporting PV staff * Build the strategy to promote and expand the PV department * In conjunction with Business Development build the strategy for the acquisition of new PV business More detailed responsibilities include: Tasks may include but are not limited to: * Develop and deliver on overall successful strategies for the future of the Pharmacovigilance department including systems and resource needs. * To manage the continuous improvement in PV processes and systems * To assume overall responsibility for the efficiency of the Pharmacovigilance department, utilizing metrics on quality and efficiency and feedback from internal and external customers. * To monitor departmental budgets, including owning of departmental revenue and other financial indicators * Have oversight of Project Performance Reports (PPRs), ensuring PV staff adheres to project budgets and timelines * To be responsible for staff allocation within the Department, ensuring enough expertise and delegating responsibility appropriately * To supervise, coach and mentor senior Pharmacovigilance staff, undertaking performance appraisals and development reviews as appropriate Support projects' deliverables as required * To identify the Department's training requirements and to provide or source training as and when required * To provide expert advice on Pharmacovigilance issues for either general processes or project specific details * To be a point of contact and escalation for Internal and Sponsor personnel * To ensure that Pharmacovigilance departmental SOPs and other non-project-specific procedures/ working guidelines are written and updated as required * To ensure the Pharmacovigilance team performs in accordance with Regulatory and Good Clinical Practice guidelines, departmental SOPs, guidelines and work instruction, and to the agreed requirements of the Sponsor * Ensure support is provided to all Business Development activities including input and review of bids and proposals, and representing Pharmacovigilance at Bid Defense meetings and sponsor meetings as appropriate * To provide Regulatory and technical advice and support on Pharmacovigilance topics to sponsors, other departments within Worldwide and to support Business development at external meetings * To represent Pharmacovigilance within WCT, ensuring that the department's capabilities and expertise are well represented * To fully co-operate with the auditors of the Sponsor company and any other staff from the regulatory authorities both during and after the project to ensure that any recommendations are discussed with senior management as appropriate and that any recommendations are incorporated OTHER SKILLS AND ABILITIES: * Demonstrated ability to lead PV activities effectively, efficiently and with limited supervision * Thorough understanding of the principles of ICH GCP and global regulatory requirements REQUIREMENTS: * Educated to BSc level as a minimum, PHD or MD preferred or with at least 10 years drug development and Pharmacovigilance experience * Extensive knowledge of global PV /drug safety processes and regulations for clinical trials and licensed products * Extensive knowledge of various PV/safety database systems * Knowledge of PV requirements in multiple geographic regions * Proven Leadership experience at least 8 years management experience * Proven experience in all clinical aspects of a trial with a strong knowledge of SOPs, regulatory reporting requirements and accepted practices * Excellent Time Management skills with ability to develop, follow and direct project plans * Excellent knowledge of budgets, revenue recognition, forecasting, and invoicing * Good computer literacy with working knowledge of PCs, Windows, Microsoft Office and Safety Database applications * Excellent oral and written communication, organizational skills and persona

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