Location: New Jersey
Our client is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
Reporting to the Associate Director, Case Management of Global Drug Safety & Risk Management, the Drug Safety Specialist will manage safety data from pre-/clinical and post marketed adverse event reports within Celgene’s 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
- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines and mandates.
- Participate in local and/or global departmental meetings
- Contribute to the hiring, orientation and training and development of staff as needed
- Maintain compliance with all required training and standard operating procedures
- Provide support and prepares for regulatory inspection
- 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 or PharmD preferred Clinical knowledge of therapeutic area, patient populations and drug class
- Computer skills and safety database experience preferred