Senior vice president & head medical safety science - united kingdom, addlestone, surrey

senior vice president & head medical safety science about astellas: at astellas we are a progressive health partner, delivering value and outcomes where needed. we pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. we work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. our global vision for patient centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. at astellas, patient centricity isn't a buzzword - it's a guiding principle for action. we believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. we work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. we deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. about this job: the global svp & head of medical safety science is a strategic leadership role, reporting to the head of pharmacovigilance (pv) with responsibility for eu, japan & us regions. the position sits as part of the senior pv leadership team and is accountable for the proactive safety surveillance of all of astellas' products, pre and post launch. the focus is to provide strategic medical safety science leadership, supporting the global pv management team and leaders across the regions. in this role the individual will provide medical advice and global strategic direction, influencing the scientific excellence within global pv at astellas. with a team of 7 direct reports and a broader team spread across the regions, this is an excellent opportunity for a senior pv leader to visualise and execute astellas' pv mission and strategic goals. key responsibilities are noted below: key focus on strategy development and execution. participates in the development and implementation of the mid-term pv mission, vision and strategic objectives. develops 1-3 year strategic and operational plans for the medical safety science function with accountability for successful execution acts as the medical safety science expert in all areas, representing pv on safety and benefit risk topics to external groups, including regulatory authorities and business partners. oversees and manages the medical safety science function, optimising structure and determining how strategy is deployed. develops and implements system of oversight which ensures technical and professional competency of all staff and a high performing team leads and is accountable for proactive safety surveillance and risk management activities to effect optimal safety signal detection, evaluation, and risk assessment/minimization across all products throughout the lifecycle. facilitates provision of medical expertise and actively builds consensus with colleagues across other departments (risk management, epidemiology and qppvs develops and oversees a center of excellence for product safety. innovates, champions, and implements best practices, including novel approaches essential knowledge & experience: solid senior experience in pv/drug safety or combined pv/regulatory affairs from within the pharmaceutical industry, preferably at a global level an in-depth understanding of drug safety regulations for both marketed and investigational products. excellent knowledge of global health authority requirements including ich, cfr 21, fdaaa, eu gvp module, jp regulations experience of planning, allocating and managing multiple projects and/or departmental budgets evidence of global managerial and leadership capabilities across a matrix environment solid medical knowledge, able to evaluate and interpret clinical and scientific data and to communicate with both internal and external customers. specific working knowledge in related functional areas e.g. epidemiology, safety signal management fluent in verbal and written english with excellent communication and presentation skills and able to work in a multicultural environment able to evidence the proactive recognition and resolution of problems or issues education/qualifications: md qualification is preferred inclusive of advanced qualification (phd) second language e.g. dutch or japanese would be useful but not essential additional information: this is a full-time permanent position and can be based in the uk or netherlands. regrettably there is no visa sponsorship or relocation budget aligned to this role we are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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