100,000's of Government Jobs

Search Government Jobs

Job Field: Security
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

---

</tr>
<tr><td valign="top" width="450"><b>Job ID:00388589Job359of371Drug Safety Associate/Senior Drug Safety AssociateSouth San Francisco, CaliforniaJob factsJob functionDrug SafetyLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionSummary of Position:The Drug Safety Associate 1 assists in thenon-clinical review, evaluation, and processing of adverse event (AE)information received by US Pharmacovigilance (USPV). Responsibilities are performed under thedirection of the US Pharmacovigilance Manager and or Clinical Drug Safetypersonnel.Job Duties/Responsibilities:* Review andevaluate AE case information todetermine required action based on and following internal policies andprocedures* Followdepartmental AE workflow procedures* Assist in specialprojects as assigned by and under the direction of the US PharmacovigilanceManager, Management and/or Clinical Drug Safety personnel* Initial Intake Team:Perform CaseReceipt of all incoming adverse events* Submissions Team: Coordinate the preparation, processing and tracking of US RegulatorySubmissions.* Documentation:Responsible for the organization, trackingand archiving of individual case safety report (ICSRs) folders and other USPV associateddocuments, and participation in the production of associated supportivedocumentation.Who You AreEducation,Experience, and Other Requirements:* High school diploma required; additional education preferred* Computer proficiency and computer data entry experience(Preferred)* Medical terminology experience (Preferred)* Writing experience; science/medical writing highly desirable* Strong organizational skills, detail oriented and adapts ina fast paced, changing environment* Work effectively as a team member and promote collaboration,actively exchanges knowledge, ideas* Demonstrates ownership, initiative and self-accountability,accepting of constructive coaching* Clear, effective written and verbal communication skills* Sound decision making abilities as demonstrated bysystematic gathering of information, appropriately assessing the complexity ofissues, a priority of tasks, in addition to making sound decisions in a timelymanner within the scope of responsibility.

KEY REQUIREMENTS:

---

Not stated