Associate Medical Director, Global Drug Safety
About the position
The Associate Medical Director, Global Drug Safety 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 Drug Safety is an individual contributor role and will be supervised by Medical/Senior/Executive Director, Global Drug Safety.
Responsibilities
• 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 GDS 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, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required
• 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
Requirements
• MD or equivalent degree required
• 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 including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions.
• Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
• Expertise with Microsoft Word, PowerPoint and Excel
Nice-to-haves
• 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 is preferred
• Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic / product area(s)
Benefits
• Collaborative culture that encourages innovation
• Diverse environment where your contributions are valued
• Opportunity to be at the forefront of rare disease research
• Make a meaningful difference in patients' lives
The Associate Medical Director, Global Drug Safety 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 Drug Safety is an individual contributor role and will be supervised by Medical/Senior/Executive Director, Global Drug Safety.
Responsibilities
• 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 GDS 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, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required
• 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
Requirements
• MD or equivalent degree required
• 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 including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions.
• Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
• Expertise with Microsoft Word, PowerPoint and Excel
Nice-to-haves
• 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 is preferred
• Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic / product area(s)
Benefits
• Collaborative culture that encourages innovation
• Diverse environment where your contributions are valued
• Opportunity to be at the forefront of rare disease research
• Make a meaningful difference in patients' lives