Senior Consultant- Pharmacovigilance - Mississauga, Canada - Q&C

Description

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.