Staffing, Recruiting & Executive Search

The Drug Safety Associate Apprenticeships are designed to help to help life sciences companies better protect patients. We use grants through our foundation to cover the costs of training and mentorship. This includes practical, on site instruction at a host company in areas such as support to drug safety management and medical monitoring activities, compliance with relevant regulations and standard operating procedures and triage of incoming reports for completeness, legibility and validity. Complementary topics such as introduction to good clinical practices, safety and adverse event reporting, investigator, sponsor, monitor roles and responsibilities, industry regulatory guidances and a recognized industry certification. Our apprentice program provides on the job training in: • Drug Safety Associate • Pharmacovigilance • Labeling for FDA regulated industry This 18-24 Month apprenticeship includes the goal of becoming an employee upon completion of program. If you are unable to directly hire the apprentice at the end they can be converted to a staffing arrangement or we can help them find a new position. Apprentices can be military veterans, students/recent graduates, mothers or fathers returning to the workforce or individuals coming off disability.

Drug Safety Associate Apprentice Responsibilities

The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Triage of incoming reports for completeness, legibility and validity.

• Initial data entry of case reports into safety database/tracking system
• Data mining/extrapolation, source data examination and cleaning
• Assessment of case reports for seriousness, causality and expectedness
• Adverse event (AE) and drug coding
• Requesting follow-up i.e. written, telephone
• Perform query resolution and initiate direct contact/follow-up with sites for additional information
• Create and maintain project specific working files, case report files and project central files
• Writing case narratives; medical and technical writing for clinical study reports and annual reports
• Inform Medical Project Managers and Regional Head of PV Operations of potential change-in scope of projects
• Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities
• Assist with additional Drug Safety activities as required

Included Instruction

• Introduction to GCP
• FDA and Institutional Review Board (IRB)/Independent Ethics Committee (IRB/IEC)
• Investigator Role/Responsibilities
• Sponsor’s Responsibilities
• Monitor’s Responsibilities
• Safety & Adverse Event Reporting
• Clinical Trial Protocol and Amendments
• Investigator Brochure
• Essential Documents
• Additional Draft FDA Guidelines
• Other Useful Documents

Find out more

Employers interested in Clinical Data Manager Apprenticeships should contact us using the form down below.

If you are interested in starting your career in one of our Clinical Data Manager Apprenticeships then submit your resume on our page for Prospective Apprentices.