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Show me jobs like this one| Job Ref: | 50393BR |
| Sector: | Business Partner Companies, Other |
| Job Type: | Full Time |
| State: | Illinois (IL) |
| City: | Deerfield |
| Post Code: | Nov 21, 2011 |
| Job Description: |
The successful candidate will be a member of the Medical Writing team in the Global Pharmacovigilance organization. The Medical Safety Writer is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world. Responsibilities include, but are not limited to: * Write and prepare standalone postmarketing aggregate safety documents for regulatory submission, such as PSURs and associated documents, and PADERs * Ensure all safety regulatory documents are processed and submitted according to regulatory requirements * Ensure data issues are addressed and resolved prior to document sign-off * Participate in ongoing safety data review and analysis for products in designated therapeutic areas * Collaborate with medical reviewers, epidemiology, and risk management concerning safety issues relative to safety writing activities * Interface with other Baxter functional groups such as Regulatory Affairs, Clinical/Medical Affairs, Quality, Information Technology, business units, as needed * Assist in preparation of function-specific responses to regulatory authority requests and of function-specific responses to assessment reports from regulatory authorities * Participate on project teams and committees as assigned Requirements Qualifications: |
| Post Date: | 11/19/2011 |
