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Senior Safety Scientist, Global Patient Safety- Remote Opportunity

 
Requisition ID:  2131
Location: 

Deerfield, Illinois, US

Date:  Dec 5, 2021
 

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 based opportunity

Summary:
The Senior Safety Scientist provides the scientific and analytical support for regulatory reporting activities that form the basis and analysis for changes to the reference safety information and risk management plan. The Senior Safety Scientist works closely with the global patient safety (GPS) Safety Lead(s) and is a member of the Safety Assessment Team(s) and contributes to the overall assessment of benefit/risk assessment of marketed products and drug candidates in clinical development.
 
Essential Functions:
•    Compiles and analyzes safety data for inclusion into safety analyses, evaluates impact and contributes in the review of the overall safety profile and risk/benefit assessment across the product life-cycle
•    Contributing member and supports activities of the assigned product Safety Assessment Team(s) and product Safety Committee(s)
•    Leads coordination and preparation of aggregate reports (i.e., PSURs/PBRER/DSUR), signal assessment activities including compiling source data. Contributes to scientific interpretation, presentation of data for review and regulatory reporting
•    Ensures regulatory compliance by providing timely, quality information for regulatory reports (i.e., PSUR/DSUR), regulatory information requests, risk management plans and signal review according to SOPs and regulations
•    Monitors report deliverables/timeline working with cross functional groups and adjusts project timeline accordingly
•    Proactively investigates trends in safety data and follows scientific methodology and logical reasoning to determine cause/effect and potential prevention of adverse events. Reports findings to the product safety assessment team(s) and safety lead
•    Evaluates signals using available signal tools, review of scientific literature and pharmacovigilance safety data. Considers impacts to benefit/risk assessment and risk characterization and incorporates into relevant documents (i.e. PBRER, RMP, Risk characterization)
•    Ensures timely communication and tracking of potential safety signals through surveillance activities to line management
•    Contributes to the development of standard operating procedures and pharmacovigilance processes for safety surveillance, aggregate reports, risk management and signal detection activities.
 
Required Education, Experience, and Skills:
•    Accredited Bachelor’s degree or higher in a health science related field (i.e. pharmacy, nursing, public health)
•    3 + years’ experience in pharmacovigilance, clinical research, medical affairs or medical writing
•    Knowledge and practical application of global regulations and guidance’s governing GxP (clinical trials, pharmacovigilance practices) 
•    Ability to analyze and aggregate data and scientific information from multiple data sources
•    Familiarity and use of data from safety databases, external databases such as FOI, Vigibase, Claims data and literature
•    Expertise with critical appraisal of scientific medical literature
•    Familiarity with Medical Dictionary for Regulated Activities (MedDRA)
•    Proven ability to produce regulatory reports (i.e., PSUR/PBRER, DSUR, clinical study reports, signal evaluation reports)
•    Ability to work independently with time sensitive documents and written responses
•    Excellent medical/technical writing skills
•    Strong oral and presentation skills and ability to communicate scientific information to internal and external audiences
•    Experience with Microsoft Office applications
 
Preferred Education, Experience, and Skills:
•    Master’s degree in pharmacy or health-related field
•    Pharmacovigilance experience
•    Global pharmaceutical experience
•    CNS experience 
•    Strong project management experience
•    Inspections/audit experience
 
Travel:
•    Willingness/Ability to travel up to 15% 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, 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: $115,000 - $140,000 and eligibility for a 15% 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 career site. 

#LI-CP1   #LI-Remote

 

Why Lundbeck

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.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

Billions of people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.  

We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion). 

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.