Global Patient Safety Lead - MD (Hybrid)

AstraZeneca GmbH; Mississauga; Hybrid; CAD 124,000 - 163,000; Full time

Job summary

AstraZeneca in Mississauga, Ontario, invites an Associate Medical Director, Global Patient Safety (GPS) to join a hybrid role (3 days in the office). You will oversee safety activities for clinical development projects and marketed products to enable safe use of our medicines.

Key responsibilities include identifying and presenting safety issues for review, preparing data for DSMBs, and serving as GPS subject‑matter expert on cross‑functional teams; you’ll assess ICSR quality and manage safety

Qualifications

• MD or equivalent degree required.
• Strong problem solving and decision‑making skills.
• Ability to manage multiple overlapping tasks and meet deadlines.
• Knowledge of GPS deliverables, standards and processes.
• Familiarity with US and EU safety regulations pre‑ and post‑marketing.

Responsibilities

• Identify and present safety issues for review at Safety Management Team meetings.
• Prepare safety data for DSMBs and safety governance meetings.
• Lead cross‑functional collaboration as GPS subject‑matter expert.
• Evaluate safety signals from ICSR and aggregate data for regulatory documents.
• Update labeling and respond to regulatory safety inquiries.

Skills

Problem solving

Multi‑tasking

GPS knowledge

Regulatory knowledge

Education

MD or equivalent degree

Job description

AstraZeneca in Mississauga, Ontario, invites an Associate Medical Director, Global Patient Safety (GPS) to join a hybrid role (3 days in the office). You will oversee safety activities for clinical development projects and marketed products to enable safe use of our medicines.

Key responsibilities include identifying and presenting safety issues for review, preparing data for DSMBs, and serving as GPS subject‑matter expert on cross‑functional teams; you’ll assess ICSR quality and manage safety