Quality Specialist - Pharmacovigilance (Remote) at Nesco Resource, LLC
Jersey City, NJ 07302
About the Job
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 .
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.
Note:
• 3 months assignment with possibility of extension.
• 100% remote role.
• Should have there own laptop or desktop to perform the work.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
• 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 .
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.
Note:
• 3 months assignment with possibility of extension.
• 100% remote role.
• Should have there own laptop or desktop to perform the work.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.