In this role, you will be processing and managing adverse events, drafting and approving GVP Quality agreements reporting to VP, Quality Services.

Knowledge and experience in the following are required:

• Process and handle adverse events on drug and natural health products and medical devices as appropriate.
• Conduct assessment of seriousness, expectedness, and reportability to Health Canada
• Prepare expedited adverse event submissions to the health regulators;
• Submit reports to health regulators and business partners in a timely manner;
• Conduct literature searches of the scientific and medical literature;
• Conduct searches in the regulatory adverse drug reaction databases (MedEffect, Health Canada, FDA and EMA as required);
• Conduct a critical analysis of safety data and assess safety signals;
• Prepare periodic pharmacovigilance reports (PSURs, ADRs, sADRs, MPRs);
• Host both client and Health Canada Pharmacovigilance audits;
• Manage Literature Searches and maintain schedule
• Conduct pharmacovigilance training
• Support sales team as pharmacovigilance Subject Matter Expert (SME)
• Manage Adverse Events Logs;
• Provide strategic support to corporate global team in the area of Risk Managment programs;
• Conduct Patient Support Programs, infusion clinics and Good Clinical Practice audits of clinical sites;
• Draft and approve GVP Quality Agreements;
• Maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents, along with advances in relevant scientific fields; and
• Have a working knowledge of ICH, GMP, GVP.

Other Skills would be an asset:

• Pharma Promotional Review and working knowledge of PAAB guidelines;
• Clinical/Non-Clinical study review and authoring summaries

Requirements

A minimum of Bachelors of Science degree in Nursing, Pharmacy, Biochemistry, Biology, Toxicology, Pharmacology, or related health science and equivalent industry experience in pharmacovigilance (at least 7 – 10 years);

Benefits

Q&C welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.