Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion AstraZeneca Rare Disease, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients. This is what you will do: The Medical Director, Global Patient Safety (GPS)is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The Medical Director will be responsible for safety activities for investigational products and/or marketed, including identification and evaluation of safety signals and risk management to drive decision-making on risk/benefit evaluation. The Medical Director, Global Patient Safetywill be supervised by Senior/Executive Director, Global Patient Safety.
You will be responsible for: Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following: Through data review and research, identifying for monthly Safety, Risk Management and Safety Science Management Team meetings, issues that could be potential signals for observed adverse events for further review and analysisChairing and/or directing the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closureRepresenting Alexion Global Patient Safety at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetingsDetecting, validating, and managing pre-and/or post-approval safety signals through to resolutionConducting medical review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and leads changes in processEvaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic and Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as neededIdentifying, initiating, and managing to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as the need arisesOverseeing safety sections of documents and safety interactions with Regulatory authorities. This may include: authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAsYou will need to have: MD or equivalent degree or a life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience2-3 years relevant safety and risk management experience in the pharmaceutical, biotech or CRO industrySound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problemsCapacity to manage multiple overlapping complex tasks to conclusion, sometimes to timelines, for several projects and sub-projects, including oversight of others working on those projectKnowledge and understanding of GPS deliverables, standards and processesKnowledge and understanding of US and EU safety regulations pre- and post- marketingThe duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have: Rare, Ultra-Rare or Orphan Disease Area experienceStrong verbal and written communication skills including making recommended courses of action to management and/or senior leaders that impact the field, department or line, and influences their decisionsExcellent, independent judgment based on knowledge and expertiseStrong personal time-management and project-management skillsMastery of Microsoft Word, PowerPoint and ExcelWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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