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
- Safety data generation, developing analysis strategies, and drawing scientifically sound conclusions based on review of various data sources for signal detection
Risk Management
- Drives risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans (RiskMAPS) and REMS programs, as relevant
- Supports the implementation of a measurement of effectiveness of additional risk minimization measures and REMS
- Designated lead on behalf of GPS-US as SME for risk management and REMS during all inspection activities from regulatory agencies as well as internal audits by R&D Quality
Medical Review and Assessment of Individual Case Safety Reports (ICSRs):
- Accountable for medical accuracy, completeness and quality of post marketing and clinical trial ICSRs, and instructs staff on appropriate follow-up
Aggregate Data Analyses and Reports (e.g. PSUR/PBRER, DSUR, PADER)
- Accountable for the scientific content and analysis of safety data/information for inclusion into aggregate reports
- Responsible for setting the strategy for data analyses and accountable for medical-scientific interpretations of aggregate data
Other Organizational Project Assignment
- Participation in relevant cross functional/GPS projects and initiatives, as assigned
- Application of specialized expertise to advance processes, methodologies and tools in line with GPS strategy, the evolving regulatory environment and healthcare trends
REQUIRED EDUCATION, EXPERIENCE, and SKILLS:
- Accredited MD/DO (MBBS, MBCHb, MBBCh)
- 5+ years drug safety experience in a biotech or pharmaceutical company
- Ability to drive drug safety evidence generation and risk mitigation strategies in a highly complex internal and external environment
- Solid understanding of aggregate data analysis and, scientific methodologies for signal detection
- Excellent analytical skills and ability to synthetize large amounts of data and to make sound medical interpretation of data
- A good understanding and experience with applying methodologies and leveraging real-world data to support and enhance PV activities
- Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs.
- Detailed understanding and ability to apply concepts of legal/regulatory requirements and guidelines to the pharmacovigilance business
- Ability to work well with modest supervision in a fast-paced environment
- Strong interpersonal, organisational 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)
- 10+ 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 - $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.
