Regional Pharmacovigilance Lead, Canada

Job summary

Lead and oversee all pharmacovigilance activities to ensure full compliance with Health Canada requirements. Manage medicinal product safety profiles and act as the primary point of contact for Health Canada inspections.

Job details

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

What you’ll do

Lead and oversee all pharmacovigilance activities to ensure full compliance with Health Canada requirements. Manage medicinal product safety profiles and act as the primary point of contact for Health Canada inspections.

Requirements

Requires at least 6 years of direct pharmacovigilance experience with expert knowledge of Canadian legislation. A clinical medicine background and experience as a PV Physician are preferred.

Listed skills

• Regulatory Compliance · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Pharmacovigilance
• Health Canada Regulations
• Safety Profile Management
• Risk Management Plans
• Drug Safety Databases
• Medical Review
• CAPA
• SOP Development
• Regulatory Compliance
• Risk Minimization Measures

Job areas

• Healthcare
• Science & Research
• Management & Leadership
• Manufacturing