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!
This position is a remote work opportunity
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 relate to a global understanding of pharmacovigilance and risk management regulations and guidelines. Individual and team contribution to the development of departmental and intradepartmental processes and procedures is expected.
Individual Case Safety Reports (ICSRs)
- Reviews post-marketing AE/SAE/PC reports and analyzes aggregate safety data; provides medical assessment; and instructs staff for appropriate query and follow-up activities
- Interfaces with Clinical team for clinical studies. Participates in clinical project meetings and in investigator meetings. Monitors safety of ongoing clinical studies by reviewing and assessing AE/SAE, lab data, providing input for further actions. Leads the preparation and review of safety aspects of clinical study protocols, CSRs, IBs, ICFs, investigator communications and IND/NDA safety updates
- Ensures accuracy, completeness and quality of post marketing and clinical trial ICSRs
- Performs medical assessment for expedited reporting of ICSRs and review of IND & EU annual reports, FDA Periodic Reports and Periodic Safety Update Reports (PSURs/PBRERs) and DSURs.
- Contributes to and provides medical safety leadership for the detailed review of the overall safety profile and risk/benefit ratio of Lundbeck products and drug candidates as directed (at intervals specified by ICH and regulatory authorities, but not less than once per year)
Risk Management, Pharmacoepidemiology and Literature Surveillance
- Leads product safety evaluation and Pharmacovigilance Plans in NDA/BLAs
- Contributes medical safety input to produce Risk Management Plans, RiskMAPS and REMS. Accountable for implementation of a measurement of effectiveness of REMS and risk management plans/RiskMAPS
- Provides medical safety input into the design and conduct of pharmacoepidemiology studies
- Ongoing review of worldwide scientific literature related to Lundbeck products as required by global regulations and internal processes and communicating safety information in the aggregate reports
- Leads the review of reports from signaling and data mining activities utilizing internal and external sources of data
- Contributes to developing methodologies for establishing thresholds for assigned product safety signal activities
- Leads periodic safety data review to identify safety signals and performs risk/benefit assessments for responsible products
- Prepares and presents information (i.e. graphs, tables and reports) related to safety profile observations to project teams and senior management
Labeling, CCDS Management and Regulatory Authorities Request Management
- Participating in discussions on company labeling management process, providing input into updates to the company core safety information and safety sections of product labels
- Participates in the development of CCDS and local labels
- Perform responsible and timely handling of safety issues/safety requests from authorities and other internal/external parties
- Leads the development and update of department systems, policies, procedures, and guidelines
- Responsible for the continuous process improvement in collaboration with the other functional areas and the Medical Safety team
- Provides direction and guidance to GPS staff for activities in case management, compliance, and risk management systems
- Participation in relevant cross functional/organizational projects
- Cross functional collaboration with other R&D functions and the GPS organization to execute on shared goals across Lundbeck
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
- Excellent analytical, organizational, written, and verbal skills
- Ability to work well with modest supervision in a fast-paced environment
- Excellent interpersonal skills with the ability to deal effectively and tactfully with providers of adverse event information and to assist others in interpretation of the data
- Excellent computer skills with experience using a Safety database
- The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation
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)
- Willingness/Ability to travel up to 5% domestically. International travel may be required.
The range displayed is specifically for those potential hires who will work or reside in the state of Colorado and Connecticut and New York City, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $250,000 - $280,000 and eligibility for a 30% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Additional 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 career site.
Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?
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.