Our client is a pharmaceutical company that specialized in lifesaving medicines and provides products and services to help critically and chronically ill patients. They are currently looking for a Vigilance Associate in the GTA.
The successful candidate will have exceptional critical thinking, analytic, and decision-making skills, and will be self-motivated and able to work with minimum supervision. They will enjoy an exciting career, a company culture based on a clear purpose and values, and hands-on experience and exposure to a global organization.
- Act as part of the Vigilance team, assisting with record keeping, safety data processing, evaluation, reporting, and quality control.
- Ensure safety data compliance with corporate and regulatory requirements for medical devices and pharmaceuticals
- Maintains knowledge of international and Canadian regulatory developments
- Responsible for collection, processing, and quality of local adverse drug reactions (ADR) data which is reported to Health Canada
- Assists with registry of Patient Support Programs, Pharmacovigilance training, Medical Device Vigilance training, PSUR compilation for local products
- Reviews incoming domestic and international complaints and field actions daily
- Assists with evaluating the reportability of events
- Other duties as assigned
- Bachelor of Science degree in Health Sciences, Pharmacy, or Biomedical Sciences, or equivalent degree in Pharmacy, Nursing, or Medicine
- 3+ years of experience in Pharmacovigilance/Medical Information and/or Medical Device Vigilance
- Written/spoken French is an asset
- Strong knowledge of relevant Health Canada regulations and ICH guidelines pertaining to Pharmacovigilance and Medical Devices
- Experience with safety case processing
- Strong scientific writing skills
- Proficient in Microsoft Office (PowerPoint and Excel)
To apply, please submit your resume using the Apply Now button.
We thank all interested applicants, however, only the candidates chosen for an interview will be contacted.