Job Information
Lundbeck Medical Director GPS US - Remote Opportunity in Deerfield, Illinois
Medical Director GPS US - Remote Opportunity
Requisition ID: 5424
Location:
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. 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
Aggregate Reports (e.g. PSUR/PBRER, DSUR, PADER)
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
Signal Management, including literature surveillance
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
Risk Management
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
Other deliverables
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
Other Organizational Project Assignment
- Participation in relevant cross functional/GPS projects and initiatives, as assigned
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 oursite. (https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf) 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 theU.S. career site (https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf) .
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 theU.S. career site (https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy) .
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 inE-Verify (https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf) .
About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.
Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.
About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.
Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.