Drug Safety Coordinator

Job Title: Drug Safety Coordinator

Job Location: Clayton, NC  

Job Duration: 12+ Months

 

·         The Drug Safety Coordinator is the first person to review the source documents for AE (Adverse Events) reports.

·         As such, the Drug Safety Coordinator (DSC) makes the first determination of report completeness and the need to perform follow-up with the reporter.

·         Maintains a basic understanding of the protocol and scope of work for clinical studies.

·         Maintains a thorough understanding and strict adherence to Good Clinical Practices (GCP) guidelines and regulatory reporting regulations.

·         Responsible for management of receipt, review and filing of literature sources that may contain AE information.

·         Serves as Global Drug Safety team member.

·         Obtains and processes all appropriate information regarding adverse event data to maintain a thorough and strict adherence to Good Clinical Practices (GCP), regulatory guidelines, and company SOPs.

·         Assists Drug Safety Scientist (DSS) and management in building team environment among assigned staff and between other departments.  

·         Identify, track, and file potential adverse event (AE) information.

·         Responsible for monitoring all incoming information and identification of potential AE information and assembling data for team meetings

·         Enter the report into the tracking log, check whether it is an initial, a follow-up, or a duplicate report and creates a case folder.

·         Identify and delete all confidential patient information from the source documents received.

·         Record protocol number and site/patient number, if applicable, on all source documents.

·         Provide the report to the person conducting case owner

·         Enter data into global safety database. Ensures accurate entry. Perform electronic or manual coding, as necessary, according to project specific guidelines.

·         Open an incident in the Trackwise database as necessary.

·         Perform a Quality check on final documents prior to a submission as needed.

·         Perform regulatory submissions according to the provided guidelines.

·         Ensure that the appropriate documentation is provided to all parties and is stored in the folder and in the designated place.

·         Support other drug safety team members with faxing reports, narratives, and queries. Place confirmations into the appropriate folder.

·         Assists DSS with adverse event follow-up, case closure, and database reconciliation.

·         Communicates problems and issues to Director/DSS in a timely manner.

·         Actively participates in DS project team meetings, providing process improvement suggestions.

·         Adheres to required timelines for completion of adverse event and product technical complaint reports.

·         Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.

 

·         Excellent technical skills required, including the ability to comprehend and integrate scientific data from a variety of sources.

·         Comprehensive knowledge of medical terminology required.

·         Excellent interpersonal, organizational, and prioritization skills.

·         Flexibility and the ability to multitask is mandatory.

·         Strong computer literacy required.

·         Must have pharmacovigilance experience.

 

·         Associates Degree or a Bachelor's Degree in a relevant curriculum and 3+ years of experience in the pharmaceutical/biotech industry preferably in the area of quality, regulatory, manufacturing/supply, information systems, clinical or drug safety, or an equivalent combination of education and experience is required.

·         Clinical drug development or Pharmacovigilance experience preferred.