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.
The Senior Safety Scientist, Aggregate Reports GPV-US provides the scientific and analytical support for the Pharmacovigilance function of aggregate reports. This position is responsible for signal evaluations and reporting activities that provide the basis and analysis for potential labeling changes to the reference safety information. Provides expertise as a scientist in area of signal analysis and is adept at interpretation of statistical methods, application of epidemiologic principles and evaluation of data generated from published medical literature and internal and external databases. Translates scientific information into summaries for action on potential signals. Works closely with the pharmacovigilance medical directors and provides supplemental scientific information to determine validation of signals. Contributes to the overall assessment of benefit/risk analysis from risk characterization of marketed products and drug candidates in clinical development.
Compiles and analyzes safety data for inclusion into aggregate reports and safety analyses; evaluates impact to benefit/risk in conjunction with medical director(s)
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 including use of external epidemiological databases, 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)
Ensures timely communication of potential safety signals through surveillance activities to line management
Conducts analyses with a systematic scientific approach across the product life-cycle
Manages and tracks signal detection activities collaborating with safety assessment team(s) and product safety lead Contributes in the review of the overall safety profile and risk/benefit assessment of marketed products and drug candidates
Collaborates with PV Medical Directors, Safety Surveillance, and Safety Systems on all activities to support preparation of aggregate reports, regulatory responses, risk characterization and signal detection
Leads coordination of signal assessment activities including compiling source data, scientific interpretation and presentation of data for analysis
Leads efforts in strategy & research of literature and drug databases and compiles source data for aggregate review in evaluation of signals
As subject matter expert, prepares and presents safety data to management and Lundbeck’s Safety Committee
Collaborates with cross-functional teams and provides safety and scientific information to assist in labeling review
Ensures expertise in pharmacovigilance and scientific area by keeping current on information from relevant scientific literature, regulations, courses and conferences
Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review according to SOPs and regulations
Monitors report deliverables/timeline working with cross functional groups and adjusts project timeline accordingly
Contributes to the development of standard operating procedures and pharmacovigilance processes for aggregate report and signal detection activities
REQUIRED EDUCATION, SKILLS AND EXPERIENCE:
Accredited Bachelor’s degree in Pharmacy, Nursing, or related health science
3 + years’ experience in pharmacovigilance, clinical research, medical affairs or medical writing
Knowledge and practical application of 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, SKILLS AND EXPERIENCE:
Master’s degree in pharmacy or health-related field
Project management experience
Willingness to travel up to 10% domestically. International travel may be required.
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, our mission is to improve the quality of life of people suffering from psychiatric and neurological disorders.
As a pioneer at the forefront of brain disorders for more than 60 years, Lundbeck is committed to developing and providing innovative therapies that help improve the quality of life of patients. This is important work because the burden of neurological and psychiatric disorders remains substantial. When we assess a medical condition, we see the person behind the disease and how it affects the lives of patients, their families, their caregivers and their communities.
What sets us apart:
Research: A deep pipeline – 100 percent targeted to brain disorders – in challenging areas like depression and anxiety, psychosis, epilepsy, Alzheimer’s disease and stroke.
Patients:A passion for patients that binds us together and drives us to act with urgency to address unmet medical needs today and into the future.
Partnerships:A long history of successful and diverse partnerships at all stages of a product’s lifecycle