Bilingual Document Specialist supporting a positive customer experience in Group Benefits Administration at Sun Life by processing documents and managing inquiries.
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.
Requirements
- 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).
Benefits
- Competitive compensation package
- Annual bonus or long-term incentive opportunities
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