Medical Safety Data Specialist Job

SENIOR MEDICAL SAFETY DATA SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Woodcliff Lake, NJ.

WHAT YOU'LL BE DOING:

- Responsible for the selection and review of appropriate codes of reported terms in clinical trials not limited to adverse events, medical history and medications.
- Ensures that the term is clear, appropriate and complete as per investigator's entry on the CRF otherwise, he/she is responsible for the coding query.
- Abstracts all necessary information from other CRF pages for concept coding if necessary.
- Assigns codes using MedDRA and WHODD terminologies, which most accurately describe each panel according to established coding guidelines and conventions.
- Some capability to perform clinical data review like aggregate AE data review, and narrative writing which include but not limited to review of demographics, medical history and the events that meet narrative writing for CSR submission
- Quantitative analysis - Performs a comprehensive review for the all the reported and coded terms. To assure the presence of all coding targets not limited to LLT, PT and SOC and Trade name, Preferred Name ATC 2 and ATC 4 and their respective dictionary versions.
- Qualitative analysis
- Evaluates the record for coding consistency and adequacy. Ensures that the selected codes accurately reflect the term as provided by the investigator. Reviews the codes for ICH compliance and adherence to coding guidelines and conventions. Adequate Clinical Data review.
- Some capability to perform clinical data review like aggregate AE data review, and narrative writing which include but not limited to review of demographics, medical history and the events that meet narrative writing for CSR submission
- Performs all duties according to company policy and regulations and guidance. Performs other duties assigned by the Associate Director. No travel required.

WHAT YOU NEED TO BRING TO THE TABLE:

- Medical Degree, Physician - Assistant or PharmD or graduate of adequate health care relatedcourse with commensurate experience in use of dictionaries in Clinical trial setting.
- Minimum of five (5) years coding experience required
- At least two (2) years of Clinical/Safety Data Review
- Strong knowledge of ICH guideline, or adequate background and have attended seminars for MEdDRA and WHODD use
- Knowledge of Central coding, Ds Navigator, INFORM a plus
- Proficiency on all related regulations, GCP, and Good Clinical DM Practice
- Computer proficiency and knowledge of medical terminology
- Expertise on use of Excel
- Strong oral and written communication skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

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

J2W: HC

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SFSF: LS