Medical Director Global Patient Safety

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!

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. The incumbent will have a strong background and experience with analyses of 'Big Data', with a good understanding of the methodologies and leveraging real-world data to support and enhance PV activities. 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 throughout the life cycle of assigned Lundbeck products. 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

• Responsible for the detailed review of the overall safety profile and risk/benefit ratio of Lundbeck products and drug candidates as directed
• Accountable for the scientific content and analysis of safety data/information for inclusion into aggregate reports

• Responsible for safety data generation, developing analysis strategies, and drawing scientifically sound conclusions based on review of various data sources for signal detection
• Ensures that safety signal and benefit-risk assessments for Lundbeck products are performed in a timely manner and any changes to the safety profile and benefit-risk balance are appropriately communicated internally to GPS management, as well as to external stakeholders
• Presents findings from signal detection activities to other Safety Team members, as well as safety governance bodies

• Maintains oversight of risk management activities and REMS programs for assigned products
• Drives risk minimisation 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 minimisation 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

• Responsible for chairing the safety committees for assigned products
• Provides medical safety input into the design and conduct of pharmacoepidemiology and observational research studies
• Provides medical safety input in relation to CCDS and label updates
• Is responsible for developing the response strategy, in collaboration with Safety Committee members, to safety-related requests from health authorities and other external parties

• Participation in relevant cross functional/GPS projects and initiatives, as assigned

• 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

• 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)

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