31 ago
|
Alexion
|
Cataluña
This is what you will do:
The Medical Director, GlobalPatientSafety (GPS)is accountable for executing 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. The Medical Director willbe responsible forsafety activities for investigational products and/or marketed, includingidentification and evaluation of safety signals and risk management to drive decision-making on risk/benefit evaluation. The Medical DirectorGPSwill be supervised byGlobalSafety Program Lead.
You willbe responsible for:
Leadingrisk management evaluation and resolution for assigned products and projects. Accountability/responsiblefor the following:
- Responsiblefor the overall scientific and clinical safety content for the assigned asset(s) or indications.
- Responsiblefor the implementation and thehigh qualitydelivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).
- Responsible for overall safety content for the product orindication(s) alignedtoGPTstrategy. Sets safety team goals aligned to TA and product strategy.
- For the assigned asset(s),responsiblefor safety TPP, Safety Go/No Go criteria, safety communication/messagingand the guidelines for toxicity management of the asset
- Responsiblefor safety contribution to study designs and study concept delivery within their assigned program
- Chairingand/or directingthe Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda frominceptionto closure
- RepresentingAlexionGPSat internal strategic and/or advisory/governance committees,other project/product team(s) orsubteam(s) as a key cross functional member and subject matter expert,and/oract as an external technical resource at DSMB or Regulatory Authority meetings
- Detecting,validating,and managingpre-and/or post-approval safety sign
📌 Medical Director, Global Patient Safety (Cataluña)
🏢 Alexion
📍 Cataluña