Title : Quality Specialist - II (Associate)
Location : 100% Remote
Duration : 3 Months with possibility of extension
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.
Note :
- 3 months assignment with possibility of extension.
- 100% remote role.
- Should have there own laptop or desktop to perform the work.
Responsibilities :
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.
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