Associate Medical Director, Global Patient Safety

AstraZeneca; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

AstraZeneca is seeking an Associate Medical Director, Global Drug Safety to lead safety and risk management activities for clinical development projects and marketed products. You will identify safety signals, conduct medical reviews of ICSRs, and contribute to regulatory documents.

This role is an individual contributor, reporting to a Medical/Senior/Executive Director in Global Drug Safety. The position requires an MD or equivalent, 1 year of drug safety experience or 3 years in a clinical

Qualifications

• MD or equivalent degree required.
• 1 year minimum drug safety and risk management experience or 3 years in a clinical care setting.
• Excellent, independent judgment based on knowledge and expertise.
• Strong verbal and written communication that influences management and senior leaders.
• Sound problem solving with innovative options for complex problems.
• Proficiency with Microsoft Word, PowerPoint and Excel.

Responsibilities

• Identify and present safety issues for review at Safety Management Team meetings through data review and research.
• Assist in preparation of safety data for DSMBs and safety governance meetings.
• Represent GDS on project/product teams as a cross-functional SME.
• Detect, validate and manage pre- and post-approval safety signals through resolution.
• Conduct medical review of ICSRs (and AOSE) and assess quality in ICSR processes; drive improvements.
• Evaluate aggregate safety data and contribute to core regulatory documents (PSURs, DSURs, RMPs).
• Initiate and manage safety updates to labeling and patient information as needed.
• Assist regulatory responses to safety inquiries from authorities.
• Support initiatives outside projects as directed.

Skills

Verbal and written communication

Independent judgment

Problem solving

Education

MD or equivalent degree

Tools

Microsoft Word

PowerPoint

Excel

Job description

This is what you will do:

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.

You will be responsible for:

Key Responsibilities include:

• 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

You will need to have:

• 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

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 is preferred
• Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic / product area(s)

Date Posted

22-Sep-2026

Closing Date

28-Sep-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.