Associate Medical Director, Global Drug Safety

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 Alexions 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 Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.

#LI-Hybrid

Annual base salary for this position ranges from 81684.80 to 107211.30.

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 candidates skills and experience job-related knowledge and other specific business and organizational 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.

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1