6 days old

Drug Safety Specialist I

Kelly Services
San Francisco, CA 94103
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 **Drug Safety Specialist** at a prestigious Fortune 500 company working in **San Francisco, CA.**

**Important information:** 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 ( ) however your resume must be received via the Submit Resume button included within.

**Job Title:** **Drug Safety Specialist**


Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies. Develops guidelines and insures the uniform and timely processing of adverse event reports. Develops and prepares reports for company management as well as external regulatory agencies. Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary. May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.


Performing complete data entry of serious adverse events received from clinical trials, according to the workflow processes and standard operating procedures. Generate accurate and complete case narratives based on information received as part of source documents including but not limited to, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites. Draft appropriate queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior Drug Safety person. Communicate or notify drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines. Maintain and track all serious adverse events reported from sponsored clinical trials for case processing relative to their priorities and submission deadlines. Support Drug Safety Department initiatives on ad hoc (as needed) basis. Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events. Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally. Ensure compliance with SOPs.

**Education, Experience and Requirements**

A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of four years experience in Drug safety or Pharmacovigilance, with at least two years hands-on experience in serious adverse event management in clinical trials evaluating investigational products is required. Experience in oncology therapeutic area is preferred but not mandatory. Familiarity with Medical terminology required. Ability to process data entry accurately. Ability to code and map data accurately. Concise case narrative (medical) writing experience preferred. Ability to prioritize work without much support. Clear effective written and verbal communication skills are essential for effective communication with study sites. Focused and detail oriented. Work effectively as a team member, promote collaboration. Self-starter and self-accountability. Relevant industry experience is highly preferred. High level of work conduct.

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_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**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect with us today.

**AboutKelly Services** ****

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 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.


Posted: 2019-07-10 Expires: 2019-08-10

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Drug Safety Specialist I

Kelly Services
San Francisco, CA 94103

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