Safety Data Assistant Job

SAFETY DATA ASSISTANT needed for a contract opportunity with Yoh's client located in Whippany, NJ.

The Big Picture - Top Skills You Should Possess:
- Drug Safety

What You'll Be Doing:
- Using multiple iterations of key data perform searches in the Argus affiliate database to identify potential duplicate information.
- Analyze the search results to determine if the information is follow-up or additional information to a pre-existing case, or if a new case needs to be created per departmental guidelines.
- Perform daily analysis between the adverse event reports received from patient support programs to the drug safety database to reconcile that all adverse events have been received and entered for submission to the Regulatory Authorities per departmental guidelines.
- Write and send queries to the patient program managers to clarify missing or incorrect information to ensure that all adverse event information is accurately reported.
- Perform weekly analysis between the adverse events received from Medical Communications and the drug safety database to reconcile that all adverse events have been received and entered for submission to Regulatory Authorities.
- Write and send queries to Medical Communications staff to clarify missing or incorrect information per departmental guidelines.
- Prioritize and accurately perform minimal data entry for both serious and non-serious adverse event reports into the Argus affiliate database per departmental guidelines.
- Scan and attach all source documents to the correct case in the drug safety database ensuring all pages have been accounted for to protect source document integrity and to ensure that documents are available for assessment globally.
- In conjunction with the Safety Information Assistant, create the case files and route the case to the next workflow state.

What You Need to Bring to the Table:
- Requires an Associate Degree in Science plus one (1) year of experience in the Pharmaceutical Industry (Drug Safety) is preferred or a High School diploma plus other post secondary education in a health care related field (eg medical technology certificate, medical office assistant) and three (3) years of experience in the Pharmaceutical Industry (Drug Safety) is preferred.
- Incumbent should have a strong understanding of medical terminology, excellent interpersonal, decision-making, and organizational skills.
- The ability to develop cooperative working relationships with all levels of staff is critical. Quality traits of diplomacy, professionalism, tact, and arbitration are important.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: SCIENTIFIC; J2W: CLINICAL

MONJOB J2WMIDATL

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