Opening For Regulatory Affairs Specialists

Company Name:
Software Specialists
Opening For Regulatory Affairs Specialists Hello We have an urgent
available with one of our clients. Kindly let me know if you will be interested in the same. Reply back with a word copy of your updated resume along with the following information.I am enclosing a brief description of the position for your review. Location: Princeton, NJ 08540 Duration: 6 months ( Contract) Job Duties: Perform monitoring of compliance, metrics and performance data Provide assistance with investigations, corrective and preventive action including root cause analysis of non-compliant single case reports (late cases) and aggregate reports Develop and revise PV Standard Operating Procedures (SOPs) Organize PV training documentation Collaborate with internal and external partners on issues and activities related to quality, compliance and training Participate in teams and committees as assigned Requirements: RN, or pharmacist with clinical experience At least 4 years of pharmacovigilance quality management experience At least 2 years in a pharmacovigilance management role Demonstrated mastery of the activities and processes related to single case processing and aggregate reporting. Signal detection and risk management experience helpful Prior regulatory inspections experience Proficient in US/EU/AP/LA regulations and ICH guidelines Exposure to working relationship with FDA and other regulatory authorities Excellent oral and written communication and interpersonal skills Ability to work with interdisciplinary, highly Matrix teams MYK62683JR

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