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Director Safety Surveillance US - Remote Opportunity

Working From Home
Start date
May 17, 2024

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Administration, Clinical, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time

Job Details

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 - If a remote hire, local presence required in the Deerfield, IL office 1-2 times a month.  


The Director, Safety Surveillance US will provide strategic leadership to the Safety Scientists to execute on PM safety surveillance activities in the US working directly with safety assessment teams, including the Safety Leads, and other US R&D teams. The incumbent will maintain oversight of safety related post approval commitments, risk minimization activities and any mandated REMS programs throughout the life cycle of Lundbeck products. This individual provides strategic direction for analyzing aggregate safety data and communicating potential changes to benefit-risk balance to GPS and R&D Management as well as to external stakeholders and customers.



  • Leads the safety surveillance activities for products assigned to the Global Medical Safety-US organization including the preparation/submission of IND and NDA related aggregate reports (IND Annual, DSUR, NDA Annual, PSUR, PBRER, RAR).
  •  Maintains oversight of signal detection, risk management activities and REMS programs.
  • Ensures that 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 and R&D Management, as well as to external stakeholders and customers.
  • Provides strategic direction to the Safety Scientists and leads the review of the overall benefit/risk profile of marketed products and compounds in development at specified intervals according to regulatory requirements and SOPs.
  • Participates in direct verbal and written communication with Regulatory Agencies on safety signals and health hazard evaluations, as required by company SOPs.
  • Provides management oversight to the Safety Scientists in performing a robust medically scientific evaluation of safety signals and ensures accurate documentation.
  • Works cross-functionally to support labeling review and proposed labeling changes resulting from recommendations by the Safety Committee to the Safety Board.
  • Designated lead on behalf of GPS-US as SME for risk management and aggregate reports during all inspection activities from regulatory agencies as well as internal audits by R&D Quality
  • Maintains oversight of strategic US PM safety surveillance projects within GPS in line with GPS and Global Medical Safety strategies
  • Utilizes subject matter expertise to further the development of pharmacovigilance science by staying abreast of state-of-the-art methodology, changes in the regulatory environment and developments and trends in healthcare system and society.
  • Identifies potential gaps and leads process optimization and implementation of new processes/procedures across GPS to ensure that the business has appropriate safety surveillance processes and systems in place in compliance with regulatory requirements.
  • Member of GPS US Management team, responsible for coaching and managing staffing needs; budget ownership of cost center, and setting strategies for the recruitment, hiring, mentoring and development of staff.



  • Accredited BS/BA in health sciences.
  • 10+ years of experience in a pharmaceutical company or the equivalent experience in a healthcare setting judged to be sufficiently related.
  • 5+ years of drug safety/pharmacovigilance experience or in an environment with a function similar to that of Pharmacovigilance.
  • 3+ years of experience with data analysis, aggregate reporting, and REMS/risk management practices.
  • Solid experience with analyses of Big Data, good understanding of 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.
  • Advanced ability to develop aggregate data and interpret, analyze, and summarize information for meaningful assessment.
  • Experience in liaising with regulatory agencies regarding pharmacovigilance matters.
  • Able to manage both timely and multiple priorities simultaneously.
  • Excellent organization and interpersonal skills, both written and verbal.



  • Doctorate or Accredited Master’s degree in health sciences, epidemiology, or public health.
  • Global pharmacovigilance experience supporting EU or Asia
  • Pre and post market surveillance experience



  • Willingness/Ability to travel up to 5% domestically. International travel may be required.
  • For remote hires, local presence required in the Deerfield, IL office 1-2 times a month.  

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: $155,000 - $195,000 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.


At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

Offices in:

  • Deerfield, IL - Lundbeck US Home Office
  • LaJolla, CA - Lundbeck La Jolla Research Center, Inc.
  • Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc


Diversity matters, and inclusion creates powerful organizations

To ensure that we reflect the diversity of our patients and their needs, we are focused on creating the context, culture, and systems where all Lundbeck employees - no matter who and where they are - can be their authentic self and perform at their best. In practice, this means that individuals feel empowered not despite their differences but because of them. We know that people are sometimes put into boxes - some of these boxes are of our own choosing and some of these boxes are chosen for us. For this reason, Lundbeck is taking a systematic, business-led approach to D&I that looks into and breaks down these boxes. Our bold action on inclusion includes an ambitious two-year plan that enables equality of opportunity through fairness and transparency, promotes openness, tackles bias and discrimination, and fosters belonging through our unique Lundbeck culture. From the highest levels of Lundbeck to the shop floor, we are working to ensure D&I is an integrated practice and mindset.


Lundbeck offers a competitive benefits package that includes:

• Medical, dental, vision effective day 1 of employment

• Generous vacation, sick leave, holiday shut down and company paid holidays

• 401k match with immediate vesting

• Parental Leave

• Hybrid work model for office-based roles

To view more details about our Benefits, please click on the link below.

Lundbeck 2023 Benefits Summary

Sustainable Development Goals

In 2020, we based the key aspects of our sustainability strategy on the UN Sustainable Development Goals (SDGs). We found we have a significant impact on seven of the 17 Goals:

• Goal 3: Good Health and Well-being

• Goal 5: Gender Equality

• Goal 8: Decent Work and Economic Growth

• Goal 10: Reduced Inequalities

• Goal 12: Responsible Consumption and Production

• Goal 13: Climate Action

• Goal 16: Peace, Justice, and Strong Institutions

Key examples are Goal 3 that is closely linked to our corporate purpose and dedication to restore brain health and Goal 13 that drives our efforts to prepare for a zero emissions future. We will use our influence and act to promote Goals 5, 8, 12 and 16. Across our sustainability actions, we are seeking partnerships with others to enable change and maximize impact (Goal 17).


Who We Are

A highly specialized pharmaceutical company that has conducted neuroscience research for more than 70 years. We develop innovative treatments to restore brain health and transform the lives of millions of people worldwide.

What We Strive For

Global leadership in brain health. Whatever your area of specialization, you will be part of our company-wide commitment to develop and advance treatments that improve the lives of people with brain disease.

What Drives Us

A culture of innovation, collaboration, and respect. We inspire curiosity, expect integrity, and pursue our achievements through knowledge-sharing, patient engagement, and the passion to deliver our end goal.

Our Societal Commitment

We understand we carry a huge responsibility for the societies we serve, and use our knowledge and voice to raise awareness, challenge standards, and increase opportunities – for patients and each other. We are at the forefront of treatment innovation, and together we continue to make a difference to people living with brain diseases.

Our Investment in You

As one way we invest in your career, we offer our employees a competitive compensation and benefit package that matches benchmark and general market conditions in our individual business locations.

Employee Satisfaction

The success of our strategy, “Expand and Invest to Grow Lundbeck” hinges on our combined competencies – and competence hinges on highly qualified and motivated employees. Our Employee Satisfaction Survey (ESS) gives us the pulse on employee motivation by asking about key elements in our work lives including management, work climate and development opportunities. We follow up on the ESS with concrete initiatives aimed at maintaining our focus on our unique workplace culture and providing personalized and aligned development opportunities for our employees.


Our Beliefs

• Patient-driven We put patients at the center of our fight for health and human dignity.

• Courageous We dare to confront unsolved healthcare challenges.

• Ambitious We set high expectations for ourselves because people in need have high expectations of us.

• Passionate We persist in developing life-changing therapies because life should not be interrupted by brain disease.

• Responsible We act with respect and integrity in everything we do



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6 Parkway North

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