Opening For Regulatory Affairs Specialists

New Jersey  ‐ Onsite
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Keywords

Description

Hello

We have an urgent job position 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

Start date
n.a
From
Software Specialists
Published at
08.03.2014
Project ID:
676486
Contract type
Freelance
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