Drug Safety/ Pharmacovigilance auditor

Pharmacovigilance Specialist will manage and ensure safety data processing, evaluation, reporting, record keeping and quality control in accordance to Health Canada guidelines and global requirements for all pharmaceutical products of the company (generic and innovator IV medications and sterile injectables).

Responsibilities including:
Maintains an efficient vigilance system in compliance with the Health Canada regulations and guidelines

Assists with data collection, assessment (including seriousness, expectedness and reportability) and entering cases of adverse reactions / adverse events.

Complete quality adverse reaction reports and submits reportable adverse reactions to Health Canada according to their regulations and guidances

Manages the write up of annual safety summary reports according to Health Canada regulations and guidances

Implementation of E2B e-reporting practice and working to ensure adverse drug reaction reports (ICSRs) supplied in E2B format can be loaded directly into the regulator’s adverse event database (e.g., Canada Vigilance).

Work with Health Canada and Global Vigilance for the implementation of the electronic reporting to HC via E2B· (effectively liaise with Health Canada and the pharmaciovigilance and IT global teams, on behalf of the Canadian market unit)

Electronic reporting (Transmission/uploading) of legacy compliance documentation for Adverse Drug Reaction (ADRs) through the Database-to-database transmission (E2B) (using the Electronic Submissions Gateway (ESG) / Common electronic submissions Gateway (CESG)).

Maintains high compliance standards with respect to reporting timelines and quality of local ADR data, as well as, with respect to responding to inquiries received from internal/external customers, by ensuring all standard operating documents are followed and that the department is inspection/audit ready at all times.

QUALIFICATIONS

Healthcare education and therapeutic expertise including an advanced background in Health Sciences, Pharmacy, Biomedical Sciences

Experience of a minimum 1 years in Pharmacovigilance/Vigilance/Medical Device/Medical Information/Adverse Event Reporting AER/Adverse Drug Reaction ADR or  possession of a Drug Safety and Pharmacovigilance Certificate
Strong business acumen and scientific writing skills

Experience with safety case processing

Ability to manage simultaneous projects with ability to determine high priorities

Advanced computer skills using Microsoft Office, Adobe, MS/LMS/Documentum/E2B

If you are interested and qualified, we invite you to email your résumé ; Henry.lukenge@neximcare.ca