Pharmacovigilance QA (PVQA) Specialist
Aurinia exists to make a difference. From the earliest days of the company, we’ve seen the potential in applying a creative, thoughtful and responsible approach to developing and commercializing therapies with a goal of changing the course for patients in disease areas that have been historically challenging to address. We Care, for our patients and our employees.
We are currently commercializing a treatment of lupus nephritis (LN) in the United States and preparing for potential commercialization of this compound in the EU, UK, Russia and Japan with Otsuka Pharmaceutical. We are also looking to leverage our internal capabilities to advance additional innovative therapies which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.
Job Description We are looking for a Pharmacovigilance Quality Assurance (PVQA) Specialist to join our Quality Assurance team who can provide broad advocacy for the continued improvement of quality standards and a quality culture across the organization.
- Supports the implementation, execution and performance oversight of the PV QMS and PV System for clinical and commercial operations.
- Contributes to PV QA Audit Planning.
- Performs PV QA audits of the PV System (activities, critical processes, vendors, etc.) and of the PV QMS.
- Supports the compilation, maintenance, and ongoing reviews of the PSMF.
- Manages PV related Deviations, Quality Issues, CAPA, Effectiveness Checks and Root Cause Analysis.
- Assists in the preparation of KPIs for PV QMS performance monitoring and Management Oversight.
- Advises stakeholders on GVP Compliance Issues.
- Participates in ongoing Inspections Readiness efforts and during inspections.
- Assists in providing GxP training to Aurinia staff.
- Contributes in the development and maintenance of Standard Operating Procedures (SOPs), and other documentation and training materials related to * * GXP Compliance and other applicable requirements.
- Supports implementation of quality related projects as assigned.
- Bachelor's Degree
- 3-5 years of relevant work experience in a PV QA related role for a pharmaceutical company (or equivalent combination of Drug Safety and Quality Assurance experience)
- Thorough knowledge of EU Good PharmacoVigilance Practices regulations (GVP)
- Thorough knowledge of US and International Safety Reporting requirements
- Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) knowledge, an asset
- Ability to deliver clear, effective communication orally and in writing
- Assumes responsibility for successfully accomplishing work and has proven experience in delivering results
- Ability to work independently as well as in a team environment
- Attentive to the details, able to recognize critical attributes, steps and functions
- Well-organized, able to switch priorities quickly, coordinate several tasks at once and make quick informed decisions
- Thrives in an environment with tight deadlines and manages oneself with a sense of initiative and urgency
- Strong working knowledge of Microsoft applications
- Ability to consistently exhibit Aurinia’s We Care values of creating opportunity, acting responsibly, relentlessly persevering, and executing with integrity in all work and interactions with employees at all levels of the organization, as well as with vendors and customers.
All your information will be kept confidential according to EEO guidelines.