Pharmacovigilance Quality Assurance (PVQA) Specialist

Contract: 1 Year (With Possibility of extension)

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.
• Primary Responsibilities:
• 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.
• 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.

Qualifications:

• 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