Director Safety Surveillance US - Remote Opportunity - Deerfield, Illinois, US

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

Remote opportunity - Open to candidates anywhere in the greater United States - If a remote hire, local presence required in the Deerfield, IL office 1-2 times a month.  

SUMMARY:

The Director, Safety Surveillance US will provide strategic leadership to the Safety Scientists to execute on PM safety surveillance activities in the US working directly with safety assessment teams, including the Safety Leads, and other US R&D teams. The incumbent will maintain oversight of safety related post approval commitments, risk minimization activities and any mandated REMS programs throughout the life cycle of Lundbeck products. This individual provides strategic direction for analyzing aggregate safety data and communicating potential changes to benefit-risk balance to GPS and R&D Management as well as to external stakeholders and customers.

ESSENTIAL FUNCTIONS:

• Leads the safety surveillance activities for products assigned to the Global Medical Safety-US organization including the preparation/submission of IND and NDA related aggregate reports (IND Annual, DSUR, NDA Annual, PSUR, PBRER, RAR).
•  Maintains oversight of signal detection, risk management activities and REMS programs.
• Ensures that signal and benefit-risk assessments for Lundbeck products are performed in a timely manner and any changes to the safety profile and …