Director Safety Surveillance US - Remote Opportunity

Requisition ID: 5214

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

SUMMARY:

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.

ESSENTIAL FUNCTIONS:

• 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.

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

• 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.

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

• 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

TRAVEL:

• 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 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.