Kelly Services, Inc.
Clinical Safety Associate
South San Francisco
Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Clinical Safety Associate
at a prestigious Fortune 500® company working in South San Francisco.
This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.
Job Title: Clinical Safety Associate I
Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
Performs Data Capture and Quality Review for all molecules and serves as a backup for additional projects.
Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
Demonstrates a general understanding of appropriate labeling documents for assigned project(s). Demonstrates knowledge and understanding of safety exchange agreements (if applicable). Participates on Study Management Teams (as applicable)
Assists in the development of drug safety presentation for investigator meeting presentations. Assists in clinical trial reconciliation process (as applicable).
Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
Ensures departmental workflow processes and timelines are followed.
Works effectively as a team member and promotes collaboration
Demonstrates initiative and accountability Strong organizational skills, detail oriented, ability to adapt to change Confident decision maker
Education, Experience, and Other Requirements
RN, BSN, PA, NP, MSN, MD, or PharmD required
Minimum 2 years of clinical experience in a health care related field
Computer proficiency and data entry experience preferred Excellent communication skills, both written and verbal Previous experience in Drug Safety (preferred)
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:
www.kellyservices.com at http://www.kellyservices.com/ .
Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Kelly Services Jobs
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.