Pharmacovigilance Analyst
PRIMARY JOB RESPONSIBILITIES:
Develop appropriate understanding of DSS case processing, required DSS and company SOPs, coding conventions, etc.
Develop 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
Report generation and authoring includes sections that PVRM is responsible for in regulatory reports (US Periodic ADE Reports, US IND Annual Reports, PSUR’s, Safety Updates for FRI NDAs and sNDAs, etc.), ad-hoc requests from regulators, requests from key stakeholders, such as Clinical, and ABPs.
Assist in developing routine and non-routine PVRM evaluations of safety data by developing 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 the medical resources in their evaluation of routine and non-routine reports, events of interest, and evaluation of potential signals
Required Skills for Pharmacovigilance Analyst Job:
- REGISTERED NURSE OR PHARMACIST WITH 2 YEARS RELATED EXPERIENCE
- DEMONSTRATED KNOWLEDGE OF AGGREGATE REGULATORY REPORTS AND PHAMACOVIGILANCE ACTIVITIES
- DEMONSTRATED TECHNICAL KNOWLEDGE OF SAFETY DATA
- DATABASES
- AND STANDARD TERMINOLOGY SUCH AS MEDRA
- EXPERIENCE WITH STANDARD SAFETY DATABASE REPORTS AND QUERY TOOLS - KNOWLEDGE OF CLINTRACE A PLUS
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.
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