Responsible for performing pharmacovigilance activities and maintaining compliance to corporate and departmental goals and worldwide regulatory timelines for OSI products. The Safety Associate works fairly independently in receiving and reviewing serious adverse event (SAE) reports for completeness, performing initial triage, data entry into the Safety database and quality review of data. Obtains follow-up information as necessary. Performs routine data queries and generates routine and adhoc reports. Creates and maintains SAE source documentation and files. The Safety Associate is responsible for preparation of expedited and periodic regulatory safety submissions and authoring the safety sections of study reports and annual reports. The Safety Associate helps identify safety signals, provides safety data queries and summaries and participates in workflow modifications, SOP updates, clinical project teams and other interdepartmental teams as necessary.
Bachelors degree preferably in a healthcare discipline and two or more years experience in a healthcare environment or the pharmaceutical industry Preferably in safety surveillance or related area. Must be proficient with MS Word, Excel, and PowerPoint
...of Position : Responsible for effectively operating assigned shift while meeting company goals for safety, quality, delivery and... ...processes are being followed: ~ Start-up and shut-down procedures ~ First and last piece inspection ~ Hourly quality checks ~5 S...
...Pediatric Hospitalist Opportunity in beautiful Richmond, VA Join Bon Secours Mercy Health in Richmond, Virginia Pediatrix Medical Group is seeking a BC/BE Pediatric Hospitalist to join our established team at Bon Secours St. Mary's Hospital , the flagship Virginia...
Job Description Job Description About the Role: A Structured Cabling Technician is responsible for the installation, termination, testing, and troubleshooting of low voltage cabling systems in commercial and data center environments. This role supports mission...
...1.21 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors. Trauma Coordinator- Day Position Highlights: Position: Trauma, Coordinator Location: Highland Park Hospital Full Time: Full Time , 40 hours per week...
...practice for adult/geriatric patients. The Regional Resource LPN will float between the designated Community Mercy Hospital facilities... ...Shift: Nights Incentives: Sign-On Bonus: $2,000 No Contract Base Pay ( Determined by Experience) PLUS Regional Float...