Medical Director, Global Patient Safety

About this role

The Medical Director, Global Patient Safety (GPS) is accountable for driving 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. Lead 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 GPS will be supervised by Global Safety Program Lead

You will be responsible for: Leading risk management evaluation and resolution for assigned products and projects. Own overall scientific and clinical safety content for the assigned asset(s) or indications. Implement and deliver high quality of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s)

Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy. For the assigned asset(s), responsible for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset Responsible for safety contribution to study designs and study concept delivery within their assigned program 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 GPS 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 Evaluating aggregate safety data and providing contributions to core regulatory documents i.e

Periodic Safety

Apply for this role on AstraZeneca’s official careers site.