The Drug Safety Associate I will support drug safety management and medical monitoring activities for clinical trials and post-marketed products, ensuring compliance with relevant regulations and SOPs.
Key Accountabilities:
- Drug Safety Support:
- Assist in developing project-specific safety procedures, workflows, and templates.
- Aid in safety database setup, data entry guidelines development, and user acceptance testing.
- Triage incoming reports for completeness and validity.
- Document and quality control drug safety information electronically.
- Enter case reports into safety database/tracking system.
- Manage follow-up requests and queries.
- Code data in the safety database.
- Write case narratives.
- Maintain project-specific working files and case report files.
- Support Drug Safety Specialists and Safety Service Project Leaders as required.
- Inform managers of potential project scope changes.
- Support Medical Directors and Safety Physicians in medical monitoring.
- Participate in client and investigator meetings.
- Attend training sessions.
- Perform literature searches.
- Prepare for and follow up on audits and inspections.
- Delegate work to Drug Safety Assistants.
- Develop Expedited Reporting Procedures.
- Register with authorities for electronic reporting on behalf of sponsors.
- Set up and deploy worldwide reporting to regulatory authorities.
- Submit safety reports to investigators.
- Track and file submission cases.
- Assist with unblinding of SUSARs.
- Review metrics for reporting compliance.
Skills:
- Analytical and problem-solving skills.
- Ability to perform database/literature searches.
- Excellent interpersonal, verbal, and written communication skills.
- Strong organizational and prioritization skills.
- Ability to work effectively in a team environment.
- Client-focused approach.
- Experience with computer applications.
