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
...We are seeking a highly skilled and motivated professionals to join our team in Shenandoah, Rockingham, and Augusta County as a PIPE FITTERS, PIPE WELDERS and WELDER HELPERS. Key Responsibilities Operate welding and fabrication equipment to assemble metal...
...United StatesCanadaFull timeJ-83590Amex GBT is a place where colleagues find inspiration in travel as a force for good and through their work can make an impact on our industry. We're here to help our colleagues achieve success and offer an inclusive and collaborative...
...of the Year, is seeking a Specifcations Writer to join either their growing Los Angeles... ...Keep in mind, this position allows fully remote working) With over 30 years of practice... ...in specification development practices Travel: Position may require occasional travel...
...Job Description Job Description Are you licensed to sell insurance and ready to elevate your business? With Aflac, you can flex your skills to help grow existing relationships and cultivate new business opportunities. Plus, youll be backed by the power, resources,...
...Job Description Job Description POSITION: Structures Engineer LOCATION: Jupiter, FL STATUS: Salary Exempt JOB SUMMARY ESSENTIAL DUTIES AND RESPONSIBILITIES The essential functions of the job include, but are not limited to, the following: Analyze Industrial...