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Kelly Services is currently seeking a Drug Safety - Pharmacovigilance Scientist in Lake Zurich, IL to work a contract assignment of 19 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.Primary Responsibilities of the Drug Safety - Pharmacovigilance Scientist includes:
Receives, assesses, investigates, processes, and reports adverse drug events regarding company drug products.
Participates in global data exchange with the company and its entities
USA partners. Interacts with the Quality and Regulatory Departments to resolve safety and quality issues.
Receives, assesses, processes, and investigates adverse drug events in accordance with global and local SOPs, and FDA regulations and guidelines.
Maintain attention to detail in reviewing, assessing and processing adverse drug events.
Utilization of critical thinking skills.
Reviews and assesses the medical literature for adverse drug event case reports.
May assist the global Adis Coordinator as required, insuring the alert settings and the literature search profile in the Adis database is up to date.
Participates in the preparation of adverse event Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR), and expedited case reports.
Maintains current knowledge of applicable local and global regulations, standard operating procedures, and guidelines.
Maintains an in-depth understanding of product knowledge, labeling, and relevant data for company products.
Maintains knowledge of all pertinent regulatory safety publications.
Interacts with the Quality and Regulatory Departments to resolve safety and quality issues.
Maintains a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.
Additional tasks and responsibilities as required.
Clinical/hospital experience preferred.
Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a product quality issue.
Ability to gather data from multiple sources and references and formulate a medicallyappropriate case narrative.
Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards (signal detection).
Must be able to prioritize and multi-task with minimal supervision, and participate in peerreview process when processing product complaints and adverse drug events.
Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required. Lotus Notes experience preferred.
Excellent written and verbal communication skills required
Responsible for Adverse Event processing and other responsibilities as requested per management: ARISg data entry, gCMW data entry and processing; literature review and case processing.
Vigilance phone responsibility with core hours (8:30 AM till 5:00 PM) .
Ability to talk with consumers / patients / health professionals / additional stakeholders in a courteous, cheerful, and cooperative demeanor at all times.
Maintains current knowkedge of applicable local and global regulations as they apply to the collection, documentation, and dissemination of adverse drug event information.
Attention to detail in reviewing, assessing, and processing of adverse events.
Ability to gather data from multiple sources and references to formulate a medically appropriate case narrative, ability to follow-up with consumers / patients/ health propfessionals/ additional stakeholders within company guidelines.
Ability to prioritize and multi-task with minimal supervision.
Excellent written and verbal communication skills.
Concise, accurate, timely, and appropriate documentation is integral.
Utilization of critical thinking skills.
Knowledge of ARISg database a plus.
Education and Experience Requirement of the Drug Safety - Pharmacovigilance Scientist includes :
Medical/clinical professional degree required i.e., PharmD, RPh, RN degree.
Minimum 3 years of drug safety and adverse drug event reporting experience required.
Pharmaceutical industry experience preferred.
Experience with preparation of adverse event Periodic Adverse Drug Experience Report.
(PADER), or Periodic Safety Update Reports (PSUR) is preferred.
Additional Information:
Contract assignment, duration 1.5 years.
Work schedule: full-time, first shift.
Kelly Temporary Employee Perks:
Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable
Service bonus plan and Holiday pay plan, if qualified
Weekly electronic pay options
Free online training campus available
Exclusive online employee community
Corporate discounts
Apply Now!This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #1728532]Thank you for your interest in the assignment.Why Kelly ® ?Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Vacancy expired!