Medical Director, GDS

2 weeks ago

Boston, United States Alexion Pharmaceuticals, Inc. Full time

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 Safety will 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 analysis
* Chairing 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 closure
* Representing 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 meetings
* Detecting, validating, and managing pre-and/or post-approval safety signals through to resolution
* Conducting 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 drives changes in process
* Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required
* Identifying, 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 necessary
* Overseeing 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 NDAs

You will need to have:

* MD or equivalent degree or a life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
* Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
* The ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projects
* Knowledge and understanding of GPS deliverables, standards and processes
* Knowledge and understanding of US and EU safety regulations pre- and post- marketing
* The 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:

* 2-3 years relevant safety and risk management experience in the pharmaceutical, biotech or CRO industry
* Rare, Ultra-Rare or Orphan Disease Area experience
* Strong verbal and written communication skills including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions
* Excellent, independent judgment based on knowledge and expertise
* Strong personal time-management and project-management skills
* Mastery of Microsoft Word, PowerPoint and Excel

#LI-RM1

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