|
Reference Number:
PZ30942Rpts
Job Description:
Please send resumes at dave@sunrisesys.com with Job id - PZ30942Rpts in the subject line.
Please include your complete name, location, availability, rate and contact information in the body of the email along with word copy of the resume.
-----------------------------------------
Job id - PZ30942Rpts
Client - Pharma Company
Title - Adverse Event Reporting Analyst
Location - Bridgewater, NJ
Duration 3 Months
Rate - Competitive
There are 3 spots with the hiring manager. In-person interview is required.
As a contracted member of the Global Distribution & Reporting Group you will work on a team responsible for the review, tracking and Global submissions of Serious Adverse Event Reports. Responsibilities include performing CIOMS I functions essential for ensuring the timely provision of CIOMS Reports to Pfizer Country Offices & Licensing Partners in order that they may be in compliance with local regulatory obligations. The specific functions include: Review of RSGT CIOMS I Target Date report notifying Therapeutic Teams and the CIOMS Manager of cases needing to be expedited. Generating RSGT report of cases with CIOMS I Requirement Status of ?Ready? verifying appropriateness of status for each case? Entering bar codes of cases on RSGT report to build a query in ARISg. Generating AEM reports for cases and formatting for attachment to e-mail; Creating a cover letter which includes cases numbers, query dates, regulatory language, initial
submission dates for follow-up cases and any necessary informational updates. Submission of report 25, and line-listing to Pfizer licensing partners? Electronically archiving cover letters, CIOMS I report, listing of serious/related adverse events and Risk/Benefit report. Archiving hard copy of initial RSGT query, preliminary AEM line listing and regulatory tracking list. Submissions to Regulatory Authorities via the electronic gateway (E2B). Maintance of E2B gateway. Review and resolution of case queries.
Experience Level:
2 Years
Requirements:
|
