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Sr Safety Scientist, Aggregate Reports

 
Requisition ID:  1192
Location: 

Deerfield, Illinois, US

Date: 
 

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.

 

Lundbeck LLC is seeking a Senior Safety Scientist, Aggregate reports GPV-US in Deerfield, Illinois.


POSITION DESCRIPTION: Provide scientific and analytical support to evaluate impact of efficacy and safety information to inform benefit/risk assessment for both marketed and investigational products; investigate and evaluate trends in data with a systematic scientific approach to allow for consistent review of all products in drug development; interpret aggregate data and communicate scientific findings and incorporation into analyses for presentations, scientific discussions, authority responses, regulatory reports, signal evaluations, risk characterizations and product labeling; author regulatory reports, scientific papers, signal evaluations, risk characterizations and labeling proposals; support local and global safety/medical activities and strategy for products including launch and life cycle management; use principles related to all phases of drug development (pre-clinical through Phase IV) to evaluate clinical data in support of pre and post approval activities; apply pharmacovigilance science, laws, and best practices to interpret data, prepare reports and meet regulatory requirements; appraise methodologies and scientific data/literature on disease states, pharmacology, clinical research and basic science/research to analyze product profile, surveillance and action for risk management; provide technical/medical writing, author scientific publications and communicates data to regulators, researchers and medical community.

 

The type of research the employee will conduct includes research pertaining to the systematic review of medical/scientific literature that includes results from clinical trials, clinical pharmacology, disease states and evolving product information on new uses or benefits and the risks of use in humans including similar information in drugs in the same class.  The specific duties the employee will be required to perform also include conducting review of the medical/scientific literature and distilling information, interpreting levels of scientific evidence on a researched topic for validation and summarizing in aggregate medical and technical content.  The overall goal of the research supports identification and recommendations for the company’s product label or investigator brochure, content for regulatory filings such as periodic reports, responses to requests for information from regulators, healthcare professionals and consumers.  


REQUIREMENTS: 

  • Master’s degree in Pharmacy or health-related field or foreign equivalent degree plus 3 years of related experience in one of the following areas: pharmacovigilance, clinical research, medical affairs or medical writing OR Bachelor’s degree in Pharmacy or health-related field or foreign equivalent degree plus 5 years of related experience in one of the following areas: pharmacovigilance, clinical research, medical affairs or medical writing.
  • Use principles related to all phases of drug development (pre-clinical through Phase IV) to evaluate clinical data in support of pre and post approval activities
  • Apply pharmacovigilance science, laws, and best practices to interpret data, prepare reports and meet regulatory requirements
  • Appraise methodologies and scientific data/literature on disease states, pharmacology, clinical research and basic science/research to analyze product profile, surveillance and action for risk management
  • Provide technical/medical writing, author scientific publications and communicates data to regulators, researchers and medical community.
     

 

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. 

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

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