Quality Specialist - II (Associate)
30 Hudson Street Jersey City, NJ 07302 US
Job Description
Target Pay Rate: 35-47.56/hr **salary will be commensurate with experienceÂ
Job Description:
Under the direction and oversight of the PV Quality and Compliance Associate Director, this role will:
• Perform reviews of individual case safety report compliance monitoring outputs to ensure high quality and compliant reporting in accordance with PV regulations and business partner agreements.
• Assist with the development and implementation of processes used to monitor the compliance of individual case safety reports
• Participate in compliance monitoring special projects as needed to ensure data quality .
Qualifications:
Education and Experience: • Bachelor's degree/Master's degree in life science with minimum 4-5 years of relevant experience within investigation, deviation in the Pharmacovigilance( PV) space. • Strong analytical skills and quality focus • Knowledge of Pharmacovigilance principles, systems, and requirements in addition to Pharmacovigilance regulations • Experience with Pharmacovigilance investigations or deviation management Software expertise: • Office 365 applications • Safety database(ARGUS is preferrable) • Will consider someone with similar software experience to ARGUS. **CO/NY candidates may not be considered
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