Clinical Safety Associate I Job

CLINICAL SAFETY ASSOCIATE I needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements
- Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
- Demonstrates knowledge and understanding of safety exchange agreements (if applicable).

WHAT YOU'LL BE DOING:

- 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.
- 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:

- Competencies Identified for Success:
- 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

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- RN, BSN, PA, NP, MSN, MD, or PharmD required Minimum two (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)

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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