Associate Medical Director, Global Drug Safety

Associate Medical Director, Global Drug Safety

Location:

Mississauga, ON (hybrid 3x a week)

When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform 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 outstanding and ambitious world!

The Associate Medical Director, Global Patient Safety (GPS) is responsible for 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 Associate 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 Associate Medical Director, Global Patient Safety will be supervised by the Global Safety Program Lead.

• Through data review and research, identifies and presents at Safety Management Team meetings, safety issues for further review and analysis
• Assists in preparation of safety data for DSMBs and other safety governance meetings
• Represents GPS on other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert
• Detects, validates and manages pre-and/or post-approval safety signals through to resolution
• Conducts medical review of Individual Case Safety Reports (ICSR) and analyzes similar events (AOSE) as needed. This includes assessing quality within the ICSR process. The role finds opportunities to improve the process and encourages changes.
• Evaluates aggregate safety data and provides 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
• Identifies, initiates and manages to completion, necessary safety updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary
• Assist in regulatory responses to safety inquiries from regulatory agencies
• May be directed by the line function to support initiatives outside of their projects

• MD or equivalent degree
• 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.

• A minimum of 1 year experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry or 3 years within a clinical care setting
• Rare, Ultra-Rare or Orphan…