Drug Safety Coordinator

Summary:

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.

• Enters the case into the tracking log and place the case in the appropriate folder.
  • Enter the case into the tracking log, check whether it is an initial, a follow-up, or a duplicate report and place the case in the appropriate folder.
  • Create a new folder for an initial case and label it.
  • Delete all confidential patient information from the received report.
  • Record protocol number and site/patient number, if applicable, on all source documents.
  • Provide the report to the person conducting case evaluation

• Enters data into safety database. Ensures accurate entry. Performs electronic or manual coding, as necessary, according to project specific guidelines.
• Performs 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.
• Serves as Drug Safety team member for Global Drug Safety projects.
• Maintains a thorough understanding of the protocol and scope of work for clinical studies.
• 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.

Knowledge, Skills, and Abilities:

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 skills, flexibility, organizational skills, ability to prioritize, and computer literacy required.

Requirements:

Drug Safety Coordinator : Associate Degree, and 2-3 years of recent experience in a clinical setting or equivalent in experience or training. **Clinical drug development or Pharmacovigilance experience preferred.

Sr. Drug Safety Coordinator: 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.

EEO/Minorities/Females/Disability/Veterans