09 oct
|
AstraZeneca
|
Barcelona
09 oct
AstraZeneca
Barcelona
This is what you will do:
The Global Safety Program Lead, Senior Director is accountable to the General Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); the professional will work with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level. Acts strategically to generate opportunity and value for the asset or indication to optimize benefit risk and maintain a competitive advantage. Line manages a team of safety physicians and / or scientists. They will be required at times to deputise for the Global Safety Head.
The Global Safety Program Lead, Senior Director will operate according to the highest ethical, quality and compliance standards in compliance as provided by global and local regulations, GxP practice and AZ procedures.
You will be responsible for:
Safety Expert
• Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.
• Accountable for the implementation and the high quality delivery 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), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset
• Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
• Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned a
📌 Global Safety Program Lead (Barcelona)
🏢 AstraZeneca
📍 Barcelona