Medical Director GPS 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

SUMMARY:
This position is responsible for monitoring the safety profile of assigned Lundbeck products according to the FDA and global regulatory Pharmacovigilance guidelines. Other key responsibilities include medical assessment of adverse events reported from post-marketing experience and clinical trials; the detection and evaluation of safety signals and risk management activities. Additional responsibilities include contribution to the development of Global Medical Safety and cross-functional processes and procedures. 
 

ESSENTIAL FUNCTIONS:
Medical Review and Assessment of Individual Case Safety Reports (ICSRs):

•  Ensures medical accuracy, completeness and quality of post marketing and clinical trial ICSRs, and instructs staff for appropriate follow-up

Aggregate Reports (e.g. PSUR/PBRER, DSUR, PADER)

• Contributes to the detailed review of the overall safety profile and risk/benefit ratio of Lundbeck products and drug candidates as directed
• Ensures timely preparation and analysis of safety data/information for inclusion into aggregate report

Signal Management, including literature surveillance

• Conducts the review of safety data from various data sources
• Presents findings from signal detection activities to other Safety Team members, as well as safety governance bodies

Risk Management 

• Contributes with medical-scientific input to Risk Management Plans, RiskMAPS …