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 and REMS, as relevant
• Supports the implementation of a measurement of effectiveness of additional risk minimization measures and REMS

Other deliverables

• Provides medical safety input into the design and conduct of pharmacoepidemiology studies
• Provides medical safety input in relation to CCDS and label updates
• Prepares responses to safety-related requests from health authorities and other external parties

Other Organizational Project Assignment

• Participation in relevant cross functional/GPS organizational projects as assigned
  

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

• Accredited MD/DO (MBBS, MBCHb, MBBCh)
• 1+ years drug safety experience in a biotech or pharmaceutical company
• Working knowledge of regulatory reporting guidelines and requirements regarding safety in the pharmaceutical industry
• Good analytical skills and ability to make sound medical interpretation of data
• Ability to work well with modest supervision in a fast-paced environment
• Strong interpersonal, organizational and communication (written and verbal) skills
• Excellent computer skills with experience using a safety database
  

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

• 2+ years of clinical practice experience in CNS Therapeutic Area (Psychiatry or Neurology)
• 3+ years drug safety experience in a biotech or pharmaceutical company.
• Advanced degree in Epidemiology and/or Master of Public Health (MPH)
  

TRAVEL:

• Willingness/Ability to travel up to 5% domestically. International travel may be required.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $240,000 - $285,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the .

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the .

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in .