Job Description

Description :

The Global Pharmacovigilance Associate is collecting, preparing and submitting adverse drug reaction reports, for products including medical devices, in accordance with Canadian guidelines & regulations and pharmacovigilance agreements to the Canadian Health Authorities and cross-license companies, respectively. The Associate also evaluates the medical literature for the detection, documentation and regulatory submission of case safety reports as well as inclusion in ASR for signal detection and evaluation.

T\xc3\xa2ches et responsabilit\xc3\xa9s :

• Collection, assessment, translation, follow-up and processing of safety information reports for both domestic and foreign adverse drug reaction cases using a dedicated safety database.
• Evaluation of the medical literature for ASR inclusion as well as for potential individual case safety reports and processing of any relevant safety cases as per the regulatory requirements
• Adverse event narrative writing
• Perform initial triage of domestic and foreign incoming safety reports received, prioritizing reports based on seriousness.
• Assist the team in reconciliation activities as needed.
• Regulatory submission of applicable ADR reports to the Health Authorities as per regulations and guidelines in effect
• Submission of applicable ADR reports to cross-license companies as per PV agreements in place
• Pharmacovigilance support and guidance to the Medical Information and Product Complaint team, as needed
• Support and participation to activities related to Pharmacovigilance audits and inspections

Skills, knowledge and abilities :

• Bilingual: French and English both spoken and written. The Associte will work in collaboration with regulatory authorities and documentation in english.
• Good knowledge of the pharmaceutical industry and of the regulatory requirements for ADR and SAE reporting
• Excellent oral and written communication skills
• Ability to work independently, take initiative and complete tasks to deadlines
• Team player with excellent inter-personal skills
• Customer-focused, detail-oriented, organized, and flexible

Education : Bachelor

Experience : 1 years: Exp\xc3\xa9rience en pharmacovigilance

Pharmascience