About the role

Pharmacovigilance Specialist ensuring safety through adverse event reporting and analysis. Collaborating with internal departments and regulatory authorities in compliance with Canadian healthcare regulations.

Responsibilities

Process individual case safety reports (ICSRs) from various sources, including data entry, writing narratives, coding adverse events with MedDRA, and assessing causality.
Conduct thorough review and analysis of safety information to identify potential signals and trends.
Prepare and submit expedited and periodic safety reports to regulatory authorities (e.g., Health Canada) within required timelines.
Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Quality Assurance) and external partners on pharmacovigilance-related matters.
Respond to inquiries from healthcare professionals, consumers, and regulatory agencies regarding product safety.
Participate in the development and updating of standard operating procedures (SOPs) and work instructions for pharmacovigilance.
Contribute to pharmacovigilance audits and inspections, ensuring compliance with local and international regulations.
Take part in risk management activities and the preparation of risk management plans (RMPs) as needed.
Stay current with pharmacovigilance regulations, guidelines, and best practices.

Bachelor’s degree in life sciences (e.g., Pharmacy, Nursing, Biology, Pharmacology) or equivalent.
Minimum of 2 to 3 years of pharmacovigilance experience in the pharmaceutical or healthcare industry.
Strong understanding of national (e.g., Health Canada) and international (e.g., ICH, EMA, FDA) pharmacovigilance regulations and guidelines.
Proficiency with adverse event reporting systems and databases (e.g., Argus, ArisG).
Experience with medical terminology and medical coding systems (e.g., MedDRA, WHO Drug Dictionary [WHO-DD]).
Excellent analytical, problem-solving, and critical-thinking skills.
Exceptional written and verbal communication skills in English and French (bilingualism highly desired).
Ability to manage multiple priorities, work independently, and meet tight deadlines.
Strong attention to detail, accuracy, and rigor in data management.
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint).