Yoh Services LLC
CLINICAL SAFETY ASSOCIATE I for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA.
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
* Drug Safety
* Clinical Safety in Health Care Field
* Excellent Communication Skills
WHAT YOU'LL BE DOING:
* 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 back up 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.
WHAT YOU NEED TO BRING TO THE TABLE:
* 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)
* 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
WHAT'S IN IT FOR YOU*
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
* Medical, Dental & Vision Benefits
* 401K Retirement Saving Plan
* Life & Disability Insurance
* Direct Deposit & weekly epayroll
* Employee Discount Program's
* Referral Bonus Program's
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Nicole Rosacia-Bernardo
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.
For over 70 years, Yoh has provided the talent needed for the jobs and projects critical to client success, by delivering comprehensive workforce solutions that focus on Aerospace & Defense, Engineering, Government, Health Care, Life Sciences, Information Technology and Telecommunications. Yoh fulfills immediate resource needs and delivers managed and outsourced solutions.