What are the responsibilities and job description for the Associate Medical Director, Global Patient Safety (Alexion) position at AstraZeneca GmbH?
The Associate Medical Director, Global Patient Safety (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 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 Safety will be supervised by the Global Safety Program Lead.
You will be responsible for :
- 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 Report (ICSR) and analysis of similar events (AOSE) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes in process.
- Evaluates aggregate safety data and provides contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans.
- 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.
You will need to have :
We would prefer for you to have :
J-18808-Ljbffr
