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| Job Location | Mississauga, ON |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Full Time |
About the RoleThe Drug Safety and Medical Information (DSMI) Coordinator is responsible for managing AE/PV inbox and supporting the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints), and handling Medical Information (MI) inquiries. The incumbent will represent the Scientific Affairs Department at Bayshore Specialty Rx both internally and externally as required and ensure compliance with Canadian Adverse Event reporting guidelines, Good Pharmacovigilance practices and Medical Information practices.A day in the LifeManage AE/PV inbox and conduct follow ups as required.Perform data entry of safety events into internal database (CRM).Retrieve source emails and source documents from the internal database.If needed, assist with collection, processing, quality check and reporting of Safety events (initial and follow-up) as per the program requirements.If needed, correct any errors that were identified in the submitted AE reports.If needed, conduct investigation for quality issues and collect all the information to complete CAPA.Conduct follow-ups for information from initial reporter and fill in gaps as necessary.If required, support with reconciliation activities as per the program requirements.If required, support/conduct activities related to source data verification as per the program requirements and/or PV agreement.Provide and support medical information services and participates in coverage after business hours, as required.Use available resources and FAQs to provide accurate and timely responses (verbal and/or written) to medical information queries.Handles, identifies and obtains pertinent data, and forwards adverse events (AEs), product quality complaints (PQCs) and medical information (MI) inquiries as per the policy and procedures.Support with audits as needed.Build excellent rapport with the internal and external customers.Job QualificationWhat you bring to the TeamDegree or Diploma in a health and life sciences related field or equivalent combination of education and healthcare experience.1-2 years of PV experience or related Healthcare work experience (in Drug/Medical Information, Medical Affairs, Regulatory Affairs, Clinical Trials or Healthcare call center environment).Bilingual (English/French) is strongly preferred.Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Global PV regulations, ICH guidelines and Pharmacovigilance auditing.Quick Apply