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Senior Patient Safety Specialist

Company: AstraZeneca
Location: Wilmington
Posted on: November 10, 2018

Job Description:

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. As a member of the Compliance Excellence team the Senior Patient Safety Specialist will be responsible for coordinating the lifecycle management of pharmacovigilance processes and technology, delivering centrally managed provision of services such as document management while meeting local regulatory requirements, and participating in research projects. Main Duties and Responsibilities In the role of Senior Patient Safety Specialist, you will lead and/or conduct a wide range of pharmacovigilance activities of multifaceted scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines. You will provide support to the Team Leader, or designee, in implementing various pharmacovigilance strategies, facilitating meetings and/or managing projects. Lead and/or contribute to the pharmacovigilance component of contracts/agreements with third parties to ensure quality and integrity of agreement. Lead personnel indirectly (as appropriate) within their respective area. You will lead managing the generation and maintenance of local Safety Data Exchange Agreements (SDEAs) and direct modifications as driven by internal or external requirements of existing agreements. Act as the pivotal point of contact for the preparation and/or revision of SDEAs or pharmacovigilance language between the US Patient Safety function and other involved functions, including Legal, Medical Information, and Regulatory, Quality Assurance and Commercial. Lead the assessment of the compliance aspects of safety data exchange agreements, for example by monitoring the timeliness of submissions and trending of compliance data. Will carry out root cause analyses for reports that are late to regulatory authorities and/or licensing partners. Be responsible for alerting senior management of any possible deficiencies in quality and compliance standards related to SDEAs and work with internal staff and external vendor and business partners to agree on corrective and preventative action. Essential Requirements * Must possess a Bachelor's Degree along with 4 years of Pharmacovigilance and/or Clinical Development experience * Minimum of 4 years of pharmacovigilance department experience to include knowledge of pharmacovigilance safety data exchange agreements and practices, including a solid understanding of FDA and other Health Authority, and ICH regulatory requirements, guidance and obligations * Proven analytical skills * Proven leadership skills * Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures * Demonstrated ability to manage multiple competing assignments and timelines * Fluent in English language with excellent communication skills, both oral and written * Demonstrated ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by lawSDL2017

Keywords: AstraZeneca, Wilmington , Senior Patient Safety Specialist, Other , Wilmington, North Carolina

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