Associate Medical Director, Global Drug Safety

AstraZeneca•Boston, MA

1d•Hybrid

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.

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)

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

Benefits

We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases.
At AstraZeneca, we’re dedicated to being a Great Place to Work.
Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.
To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
There is no better place to make a difference in medicine, patients, and society.
An inclusive culture where you will connect different thinking to generate new and valuable opportunities.
Where you will find a commitment to lifelong learning, growth and development for all.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We’re driven to make the right choices and be accountable for our actions.
As an organisation centred around what makes us human, we put a big focus on people.
Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
And, together with your team, you’ll shape a culture that unites and inspires us every day.
This is your life at AstraZeneca.