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
...Position SummaryThe EHS Manager is responsible for leading all environmental, health, safety, and regulatory compliance activities for Barksdale's Los Angeles manufacturing facility. This role serves as the site's subject matter expert and strategic leader for EHS, driving...
...FT Proctor The Bridgewater-Raynham Regional School District is seeking a full-time proctor for the 26-27 school year. Assignment will be at the George Mitchell Elementary School. Primary duties are to assist in the library. May be willing to cover positions within...
High School English Tutor (Instant)Join to apply for the High School English Tutors (Instant) role at Varsity Tutors, a Nerdy Company . The Varsity Tutors Live Learning Platform has thousands of students looking for immediate online High School English help...
...Stylist Assistant at Job Description Our busy full-service Hair Salon is looking for experienced Stylist Assistants to work with our talented team in all aspects of hair design. Previous salon experience is preferred.Requirements Current NYS cosmetology license or currently...
...learning, and work-life balance.They are seeking a talented Web Designer to create and update engaging user experiences for their sites... ...while making a tangible impact.This is a fully remote freelance position paying $60-70/hr .Responsibilities: Concept and implement...