Associate Medical Director, Global Drug Safety
Location: Mississauga, ON (hybrid 3x a week)
Introduction to the role
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 Alexion27s 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 Safetywill be supervised by the Global Safety Program Lead.
What you27ll do:
- 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
Requirements:
- 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.
Desirable:
- 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 Disease Area experience
- 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
- Excellent, independent judgment based on knowledge and expertise
- Strong personal time-management and project-management skills
- Mastery of Microsoft Word, PowerPoint and Excel
Ready to lead and encourage? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.
#LI-Hybrid
Annual base salary for this position ranges from 123,960.00 to 162,697.50.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. 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. The base pay offered will vary depending on multiple individualized factors, including the candidate27s skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
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 weeks27 paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
