Pharmacovigilance Business Specialist

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Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: Position Summary The PV Business Manager will report to the Sr. Director, PV Operations and will be responsible for managing business related day to day function within GPV and oversee and maintaining all budgetary activities. The candidate will also support the post marketing & clinical trial lead(s) in safety vendor oversight including KPI & financial metric monitoring along with resolving business related issues as well as financials. The candidate will liaise with internal & external functions to resolve contracts related activities for PV. The PV Business Manager will support the business’ goals and objectives by identifying deficiencies and opportunities within the business, and then developing and implementing best practices. Principal Responsibilities Prepares, administers, and analyzes departmental budgets; resolves budget issues; develops and administers financial policies; processes budget requests, justifications, expenses, and revisions, and monitors revenues and expenses. Prepare and maintain the PV budget, obtain approval from PV Leadership, and collaborate with Alexion Financial Department regarding approval and updates to the budget. Works with Procurement and Legal for contract approval on new vendor engagement or updates to previously approved contracts Manages the developmental business plans and contracts, provides daily management of programs, practices, and contract services; support and assists with financial preparation for external agreements; performs strategic analysis of business plan including implementation; assesses services to determine business needs. Performs cost analyses and creative cost containment; identifies weak fiscal financial performance; recommends financial solutions and implements corrective action plans; develops and prepares statistical reports. Manages departmental financial accounts; approves transactions (including time monitoring for contract employees); reviews and maintains financial records; assures accurate and timely reporting procedures on fiscal activities; reviews bid proposals and invoice transactions; assists with resource distribution; oversees purchasing, billing, and accounting. Support departmental related human resource activities; tracks open position count and collaborate with Financial and Human Resources to support a fully staffed PV team. Manage & organize global PV meetings and track major pharmacovigilance deliverables Collaborate with PV Project Leaders to assure development of the project plan, team lists, maintenance of central files, and generation of financial metrics. Develop a monthly business report for all GPV activities for GPV leadership & Senior management Collaborate with the Director of Quality, Training and Compliance to monitor and analyze key performance indicators especially as relates to external vendor activities. Provide information to the team by assembling and summarizing data, preparing reports, and making presentations of findings and recommendations. Project manage PV initiatives as requested and provide oversight on business continuity plans Performs special projects and other duties as assigned. Qualifications At least 3-5 years’ of business management or related experience Pharmacovigilance experience preferred Knowledge of business, budget, and financial processes and practices Knowledge of financial guidelines and terminology Planning/organizational skills Research and analytical skills Interpersonal/human relations skills Verbal and written communication skills Supervisory skills Strong proficiency in use of personal computer software, and databases Ability to analyze and interpret reports, documents, and statistical data Ability to integrate budgeting and financial functions with management techniques Ability to function independently, with appropriate initiative, creativity, and attention to detail Ability to exercise sound judgment in complex situations Education Bachelor’s degree; supplemented with three (3) years of related experience As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit or download our App for iPhones and Blackberries. Alexion is an Equal Opportunity /Affirmative action employer
Phama Job Categories: 
Clinical research and pharmacovigilance

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