Description
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. As an Associate Medical Director, Global Drug Safety, you will be 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 role involves identifying and evaluating safety signals, managing pre-and/or post-approval safety signals, conducting medical reviews of Individual Case Safety Reports (ICSRs), and providing contributions to core regulatory documents such as Periodic Safety Update Reports and Risk Management Plans.
Key responsibilities include:
- Identifying and presenting safety issues for further review and analysis at Safety Management Team meetings
- Assisting in the preparation of safety data for DSMBs and other safety governance meetings
- Representing GDS on other project/product teams or subteams as a key cross-functional member and subject matter expert
- Detecting, validating, and managing pre-and/or post-approval safety signals through to resolution
- Conducting medical reviews of ICSRs and analysis of similar events (AOSEs) as necessary
- Evaluating aggregate safety data and providing contributions to core regulatory documents
You will need to have:
- A MD or equivalent degree
- A minimum of 1 year experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry or 3 years within a clinical care setting
- Excellent, independent judgment based on knowledge and expertise
- Strong verbal and written communication skills
- Sound problem-solving skills
- Expertise with Microsoft Word, PowerPoint, and Excel
We would prefer for you to have:
- Rare, Ultra-Rare, or Orphan Disease Area experience
- Strong personal time-management and project-management skills
- Knowledge and understanding of US and EU safety regulations, CIOMS, ICH, and GCP guidelines
- Clinical development/research experience
- Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic/product areas