Primary Functions:
- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and product requirements.
- Detailed knowledge of the following guidance documents. Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102); Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063);
The Marketed Health Products Directorate (MHPD) guidance documents: Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publi cations/medeffect-canada/preparing-submitting-summary-reports-marketed-drugs-natu ral-health-products-guidance-industry.html
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publi cations/medeffect-canada/guidance-document-submission-risk-management-plans-foll ow-commitments.html
- Assist in performing Pharmacovigilance activities for all Mint marketed drug products and API molecule level including but not limited to, collecting, and tracking incoming Adverse Drug Reactions, medical inquiries and end point follow up information.
- Assist in prepare line listing for all the ADRs received.
- Assist in keeping records for nullifying ADRs with justifications.
- Facilitate to compile ADRs, Completed CIOMS and submit to Health Canada as per the guidance.
- Assist in performing literature searches and Canada vigilance database searches.
- Liaise with Regulatory Affairs department for tracking requirements and electronic reporting if required.
- Ensure to meet quality, productivity, and delivery standards per project requirements.
