2 Remote Product Safety Data Surveillance/clinical
Company: Kyyba, Inc dba Asen
Location: North Chicago
Posted on: May 3, 2021
Job Description 2 Remote Healthcare/clinical professionals for
Safety Data/ Surveillance/Literature JP11193/11194 43-48.00 an hour
w2 contract through end of the year Responsible for standard
surveillance activities for a products life cycle (one or more
assigned compounds and products) through review of safety data from
clinical trials, safety databases, and the literature.
Collaborates with safety and clinical teams to develop strategies
and approaches for signal assessments and regulatory requests by
analyzing data from multiple sources.
Analyzes data to support signal assessment and contributes to ad
hoc regulatory safety requests using data from multiple sources
Utilizes medical judgment to determine the impact of identified
safety issues on the compound/ products benefit-risk profile.
Communicates findings of surveillance activities and safety
assessments to product teams and leadership to inform on necessary
risk minimization activities, including label changes.
Collaborative preparation and maintenance of safety sections of
Clinical Summary of Safety, Clinical Study Reports, Company Core
Data Sheets and Risk Management Plan.
Support strategy development, authorship and review of global
aggregate safety reports in accordance with regulatory requirements
and standard operating procedures with supervision.
Prepares summaries of key safety data for PST, SRB, senior
management, Advisory and other similar meetings with
Proficient in pharmacovigilance regulations, guidelines, and
company standard operating procedures In depth understanding of
compounds within assigned therapeutic areas, including safety
profile and where applicable, labeling, literature, clinical and
regulatory issues. Qualifications: Degree in a Health Sciences
(e.g., Pharmacy, Epidemiology, Nursing); o Bachelors + 2 years
clinical/pharma or safety work experience o Masters or doctorate,
1-2 years clinical/pharma or safety work experience (e.g. MPH,
PharmD, PhD, or Masters in a Health Science) Knowledge of the drug
development process which includes conducting clinical trials,
scientific strategy and operations management for the planning,
execution and reporting of clinical development programs,
regulatory requirements for submission, product launch and post
Understanding of tools, standards and approaches used to
efficiently evaluate drug safety is desirable, not required.
Familiar with working in a multidisciplinary, matrix team situation
Effective oral and written communication skills with the ability to
manage multiple projects simultaneously Microsoft WORD and EXCEL
skills and Basic Project Management skills Able to work
independently with guidance from manager Company Description Kyyba,
Inc. is a global workforce management and technology solutions firm
headquartered in Farmington Hills, Michigan with multiple locations
across the globe. Our expertise is in connecting the right people
with the right opportunities. We deliver high-quality solutions and
top-notch recruiting services, enabling businesses to effectively
respond to organizational changes and technological advances. Kyyba
offers IT, Engineering, Professional, customized project solutions
and Business Consulting Services. Industry areas include but are
not limited to Automotive, Education, Financial Services, Public
Services, Aerospace & Defense, Insurance, Transportation,
Technology, Government, Healthcare & Medical, Manufacturing, and
Oil & Energy.
Asen has been in business since 1975 and we are 1st tier
preferred vendors for our MSP,VMS clients. Fortune 500 companies.
We stay in the top 5 on most recent report cards for IT,Clinical,
Creative and Engineering. We are an equal opportunity employer.
Keywords: Kyyba, Inc dba Asen, Waukegan , 2 Remote Product Safety Data Surveillance/clinical, Other , North Chicago, Illinois
Didn't find what you're looking for? Search again!