Pharmacovigilance Quality Assurance Specialist

McKesson•Mississauga, ON

6d•CA$56,800 - CA$75,700

About The Position

The Pharmacovigilance Quality Assurance Specialist is an integral part of the Pharmacovigilance team responsible for providing ongoing support to aid the daily business functions of the organization.

Requirements

University Degree or College Diploma in a related field or equivalent (University Degree in Health Sciences is preferred)
2+ years of experience with/in case management/program management experience and/or previous pharmaceutical brand management experience or equivalent, specific to oncology, neurology, or specialty drugs is considered an asset
Excellent communications skills, verbal and written in English
Experience in the healthcare, pharmaceutical, o
Insurance industry is an asset
Strong computer skills using MS Office (Excel, Word)
Highly organized with strong attention to detail
Ability to apply critical thinking skills in order to resolve problems
Proven ability to manage time, set priorities, and multi-task in order to meet various competing work deadlines
Team-oriented, with the ability to work independently

Responsibilities

Identify, author, track, and manage Pharmacovigilance deviation and privacy incident reports
Conduct Pharmacovigilance deviation investigations
Support in the identification of root cause and corrective and preventative actions
Ensure corrective and preventative actions are completed in time by relevant stakeholders
Update program documentation as required by the client, including program organizational charts
Produce client-facing reports on Program’s compliance and effectiveness and present data to Client in a professional, organized, and constructive manner
Evaluate work processes and documentation to ensure they meet manufacturer compliance requirements and fully respond to deviation root causes
Lead the training of new CAPA processes to ensure full understanding by Program stakeholders
Instructor-led live Safety training coordination
Manage client-issued Pharmacovigilance training and training records
Provide support during audits, as required
PV Reconciliations (Daily/Monthly/Quarterly)
Main POC for PSP teams on matters related to AE reporting
Assist in the development of new work and processes in response to identified Root Causes and in pursuit of robust Corrective and Preventative Actions
Identify and implement metrics to evaluate the effectiveness of process improvements