Drug Safety Assistant (12-174) FibroGen
THIS JOB HAS EXPIRED Description:
The Drug Safety Assistant will provide technical, process-related and Drug Safety related management activities.
Assist FibroGen Drug Safety Directors as needed in all project-related tasks such as partner contractual responsibilities, vendor?s interactions and other regular and punctual events of compliance readiness.
Follow-up requests for safety data i.e. e-mails, written, telephone;
Safety database vendor documentation management/ tracking system activities;
Assist regulatory authority reporting (electronic and hard copy) including the compilation of regulatory authority
DMC correspondence & reporting package assistance
Case reconciliation; supporting Line listing and tabulation generation for safety reports preparation i.e. periodic safety reports
Quality control of safety line listings and tabulations and Ad hoc query resolution
Safety training material preparation and dissemination.
Safety Quality Assurance activities such as assisting in audits, development of templates and guidelines
Preferred some Nursing, Life Science, or other health-related field, Healthcare and/or pharmaceutical industry-related experience preferred.
Considerable experience with computer applications including word processing, spreadsheet, presentation and database management systems
Understanding drug safety and the drug or willing to learn and be trained on drug safety specific activities.
Knowledge of medical terminology preferred, but not essential
Experience in clinical development process preferred, but not essential.
Good interpersonal skills good time management skills i.e. ability to manage multiple and varied tasks and prioritize workload as well as a team player
||San Francisco, CA |
THIS JOB HAS EXPIRED