Medical Director Global Patient Safety (GPS) 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? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

SUMMARY :

This position is responsible for strategically managing the safety surveillance and risk minimization activities for assigned Lundbeck products throughout the life cycle from late-stage assets to marketed products. The incumbent will have a strong background and experience in pharmacoepidemiology principles, with a good understanding of the methodologies in leveraging real-world data to enhance patient safety. This individual has a solid understanding of global PV regulations and maintains oversight of safety related post approval commitments, risk minimization activities and any mandated REMS programs. This requires establishment of strategic partnerships within R&D organization, staying abreast of developments in neuroscience and patient safety fields, and adhering to the highest quality and ethical standards.

STRATEGIC FUNCTIONS :

• Designing safety evidence generation and patient-centric risk minimization strategies
• Planning and interpretation of safety data analyses and advancing methodologies in line with healthcare trends
• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies
• Chairing multi-disciplinary safety committees for assigned products
• Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties

OTHER CORE SAFETY RESPONSIBILITIES

Signal Management and literature surveillance

Risk Management

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

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

Other Organizational Project Assignment

REQUIRED EDUCATION, EXPERIENCE, and SKILLS :

PREFERRED EDUCATION, EXPERIENCE, and SKILLS :

TRAVEL :

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 - $280,000 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 site. 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 U.S. career site .

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 U.S. career site .

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 E-Verify .

Salary : $240,000 - $280,000