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
...Description Part-Time Bookkeeper Location: Onsite Saginaw, MI Pay: $20/hour Schedule: Part-time, 16+ hours per week (flexible... ...Quarterly Reconcile intercompany balances and process cash transfers Calculate and record management fees Prepare financial...
...(ISR), and logistics. Job Description Overview SOSi is actively seeking qualified, professional, and experienced Spanish interpreters in El Paso, TX. The Spanish interpreter will be supporting a broad set of business activities from a call/contact center...
Network Systems Specialist Job Overview: Join our team as a Network Communications Systems Specialist... ...contributing to seamless operational support. Requirements: Attend a 29-week paid... ...Equipment Installers and Repairers, Computer System Analyst. About Our Organization...
...Telephone OperatorTo receive and relay incoming and outgoing telephone calls on the university system to include scheduling and implementation of multi-party conference calls. To provide directory information, transfer calls, and clerical support as required.High school...
...Drug Safety Associate 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...