When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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.
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)
At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
Ready to lead and inspire? and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.
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Annual base salary for this position ranges from 81,684.80 to 107,211.30.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
