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Job Title: Drug SafeyAnalyst - PVRM
Job Location: NJ: Orange
Pay Rate: Open
Job Length: full time
Start Date: 2008-09-16

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: Drug Safety Analyst - PVRM



The PVRM Analyst position continues the development and enhancement of the Medical Surveillance and Risk Management (MSRM) activities in Drug Safety Surveillance (DSS). The position implements global guidelines concerning good pharmacovigilance practices including the generation of regulatory aggregate reports encompassing Periodic ADE Reports, Safety Summary of IND Annual Reports, various line listings for inclusion in PSURs and assist in preparing and generating ad-hoc reports in response to both internal and external inquiries. Duties include: assisting PVRM Manager and Physician staff members in developing routine and non-routine PVRM evaluations of safety data by generating reports from a variety of data sources, including the corporate safety database and safety data from ABPs, and author a preliminary report describing methodology and factual summaries of output to assist in the evaluation of routine and non-routine reports, events of interest, and evaluation of potential signals, execute routine aggregate regulatory reports such as US (A)NDA Periodic ADE Reports, summary sections for US IND Annual Reports and various components of Periodic Safety Update Reports, create and execute ad-hoc requests from regulators, and requests from key stakeholders, such as Clinical and ABPs, support signal detection activities through report generation, formatting, and structure of data, research and evaluate product safety for products currently marketed, proposed and in development, respond to safety assessment requests and medical inquiries as assigned, prepare analyses for product quality complaints and work with Clinical to prepare for Clinical Trial Case Handling. Additional job responsibilities include: the development of appropriate understanding of DSS case processing, required DSS and company SOPs, coding conventions, etc. and development expert technical understanding of the relational design and structure of the corporate safety database and data variable definitions, as well as similar information in other safety data sets, such as those from clinical trials sponsored by FRI and/or its ABPs. Education requirements include: Registered Nurse or Physician Assistant. Experience needed: minimum 2 years experience in Drug Safety or the pharmaceutical industry, experience with standard safety database reports and query tools - knowledge of ARISg a plus, demonstrated writing/authoring capability. Knowledge, skills, and abilities include: understanding of FDA and international regulations, knowledge of aggregate regulatory reports and Phamacovigilance activities, understanding of Drug Safety processes (including relevant SOPs, WDs), documentation, requirements, and organization, basic understanding of products, clinical Safety subject matter expertise, ability to apply medical judgment to Drug Safety, technical knowledge of safety data, databases, and standard terminology such as MeDRA, technical expertise with safety databases and commercial query tools to generate and format reports, ability to work collaboratively a team environment, ability to prioritize work and meet deadlines, understanding of supporting technologies, including ARISg, basic MS Office applications, strong verbal and written communication skills in a medical or scientific context and strong analytical skills.

Please refer to Job code TP5595 when responding to this ad.

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