Drug Safety Associate Apprenticeships
Drug Safety Associate Apprenticeship opportunities with local companies
The Drug Safety Associate program is an 18-24 month apprenticeship designed to train for a career as a drug safety associate within the scientific products industry 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.
Earn while you learn in these areas:
- Drug Safety Associate
- Labeling for FDA regulated industry
Each apprenticeship opportunity includes a certification upon completion.
This 18-24 Month apprenticeship includes the goal of becoming an employee upon completion of program. 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.
Drug Safety Associate Apprentice Responsibilities
- 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
- 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
Host an Apprentice
If you are interested in hosting an apprentice for the duration of the one to two year apprenticeship, please contact us now. We will set up a call to determine your eligibility and answer all your questions.