Regional Pharmacovigilance Lead, Canada - kamloops

Bilinguallink; Kamloops; On-site; CAD 120,000 - 150,000; Full time

Job summary

Bilinguallink in Canada seeks a Reg PV Lead to manage all pharmacovigilance activities in compliance with Health Canada requirements, with support from the global PV system.

The role requires 6 years PV experience, clinical medicine background, and fluency in English, with strong communication and collaboration across PV physicians and QA teams. Occasional travel may be required.

Qualifications

• Clinical Medicine background preferred.
• 6 years of direct PV experience required.
• Familiarity with Canada pharmacovigilance regulations and related systems.

Responsibilities

• Acts as Reg PV Lead (Designated Person for PV) to ensure Health Canada compliance.
• Contributes to global PV system, including QA and training documents.
• Manages safety profiles and emerging safety concerns.
• Collaborates with PV Physicians for medical review of safety reports.
• Acts as PV contact to Health Canada and supports PV inspections.
• Keeps up-to-date with Health Canada PV regulations and implements changes.
• Monitors obligations from MAAs and other safety commitments.
• Contributes to EU risk management plans and local Canadian appendix.

Skills

Fluent in English

Strong communication

Presentations

Education

Clinical Medicine background

Tools

Argus

ARISg

SharePoint

Job description

POSITION ACCOUNTABILITIES

• 1- Acts as Reginal PV Lead (Designated Person for PV) to lead and oversee all PV activities to ensure compliance with Health Canada requirements with the support from Henlius’ global PV system.
• 2 – Contributes Henlius global PV system, including its quality system, such as PV-related procedural documents (e.g., SOPs), PV training of personnel, Audit associated documents, PV system deviations and related CAPAs, to ensure fully compliance to Health Canada requirements.
• 3 – Manages the medicinal products’ safety profile, including any emerging safety concerns.
• 4 – Cooperates with PV Physicians from headquarter for the medical review of safety reports and or safety relevant document.
• 5- Acts as a PV point of contact to Health Canada and as a primary contributor for PV inspections from Health Canada.
• 6- Maintains up-to-date knowledge of current Health Canada PV regulations/ guidelines, and collaborates with relevant functions on implementation of changes in regulations/ guidelines.
• 7- Has awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to the safety or the safe use of the products.
• 8. Contribute EU Risk Management Plans (RMPs) and manage Canada local appendix and implementation.
• 9. Review additional risk minimization measures (aRMMs) and manages the local implementation as needed.

QUALIFICATIONS

Education

Clinical Medicine background preferred.

Work Years

6 years of direct PV experience (mandatory requirement). PV Physician working experience preferred.

Experience Requirement

• Demonstrate expert knowledge in Canada pharmacovigilance legislation, skilled and knowledgeable in all aspects of pharmacovigilance, PV system and relative function.
• Familiar with products safety profile management.
• Strong interpersonal and presentation skills; exhibits professional maturity, confidence, and competence.

Skills

• Fluent in English.
• Computer skills (e.g., Word, Excel, Outlook, SharePoint).
• At least familiar with the use of one drug safety database, such as Argus, ARISg etc..

Competency

• Excellent organization skills and sense of urgency/working to tight timelines.
• Ownership of tasks, open mind, flexible, good communication.

Others Requirements

Travel frequency: Occasional travel