Drug Safety Associate
Newark Metro Area, NJ
- Education: Minimum of B.S. or the equivalent combination of relevant education or professional experience. Current registered medical license preferred.
Experience: Two (2) years of clinical experience; RN, RPh, or PharmD preferred
Knowledge: Clinical knowledge of therapeutic area, patient populations and drug class
Knowledge: Computer skills and safety database experience preferred
- Drug Safety Specialist will manage safety data from pre-/clinical and post marketed adverse event reports within central safety database. The Specialist will ensure that individual adverse event case reports are evaluated, investigated and accurately computerized
Responsibilities will include, but are not limited to, the following:
Conduct the assessment of all serious individual adverse event case reports stemming from pre-/clinical studies, post-marketed and literature sources.
- Performs quality control of key data fields, and makes updates in the safety database per process conventions
- Executes case assessment (review events, determine expectedness, review/update drug and medical term coding, determine causality)
- Creates clear, medically concise case narrative procured from relevant information in form of various source documents
- Drafts pharmacovigilance company comment
- Determines follow-up actions and generates letters/queries as appropriate
- Ensures individual case reports are accurate, complete and timely for regulatory reporting purposes
Support the identification of case corrections and creation of updates in the safety database following medical review.
Execute phone and/or email communication with customers and interdepartmental groups as necessary.
Manages to phone calls directed to drug safety regarding AE reports, and general queries.
Support the triage of cases conducted by the Senior Drug Safety Specialist as needed
Supports the management of case processing deadlines for aggregate safety reporting