Associate Medical Director, Global Drug Safety When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. 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.

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.

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 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 US and EU safety regulations pre- and post- marketing The duties of this role are generally conducted in an office setting. 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; 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 Strong verbal and written communication skills cover making recommendations to management or senior leaders. These suggestions impact the field, department, or line and influence their decisions Strong personal time-management and project-management skills Mastery of Microsoft Word, PowerPoint and Excel Canada’s Most Admired Corporate Culture View our YouTube channel At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued.

Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).

Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days.

Fixed Term

Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

📌 Associate Medical Director, Global Drug Safety (Mississauga)
🏢 AstraZeneca
📍 Mississauga