Drug Safety Records Coordinator Job

DRUG SAFETY RECORDS COORDINATOR needed for a contract opportunity with Yoh's client located in Berkeley Heights, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Drug Safety

WHAT YOU'LL BE DOING:

- Initial receipt and preliminary data entry of AE case reports
- Initial AE case report completeness review
- Determination of non-AEs
- Identification of product quality reports
- Process due diligence reports
- Undertake additional assignments on an as-need basis.
- Interact with internal departments to resolve questions /
- AE Case Management.
- Co-ordinate the receipt of AE case reports, specifically:
- Retrieve source documents from databases and/or retrieve case in ARISg
- Initial and date stamp source document, if applicable
- Process receipt of self-evident follow-up as new version in ARISg
- Check initial source doc completeness
- Initiate follow-up if needed & log communication in ARISg
- Perform duplicate search for each document
- Identify exact duplicate source doc, attach to case in ARISg, enter communication log
- Perform initial data entry in ARISg
- Determine if AE/Non-AE
- Identify Non-AE follow-up needs and generate letters and attachments
- Identify PQ complaint and notify Quality
- Create PDF, if applicable
- Create initial case
- Attach electronic documents to case in ARISg
- Execute exchange of information (eg contractual partners, Alkeran)
- Print, assemble and send follow-up letters/queries and attachments for all cases

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of one (1) year in the Pharmaceutical industry.
- Experience in drug safety setting a plus.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W: CLINICAL

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