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Mailbox Handling
3 weeks ago
**ABOUT THE ROLE**
The Mailbox Handling and Triage Coordinator, Drug Safety and Medical Information (DSMI) is responsible for primarily managing AE/PV inbox, Query handling 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.
**Please note: This is a work from home role requiring ability to work from our Mississauga office if/when required. Also, this role requires extended hours of working beyond regular business hours, and including weekends and/or stat holidays.**
**A DAY IN THE LIFE**
- Manage AE/PV inbox and conduct follow ups as required.
- Triage and assign cases to team members as per program/product alignment.
- Assess Date of awareness of all incoming AE reports and triage for timely reporting
- Assign a due date for all incoming AE reports and tracking completion of all due reports.
- Perform data entry of safety events into internal database (CRM).
- If needed, assist with collection, processing, quality check and reporting of Safety events (initial and follow-up) as per the program requirements.
- As needed, correct any errors that were identified in the AE reporting forms.
- As 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.
- Mentoring and training new DSMI Coordinators
Job Qualification
**WHAT YOU BRING TO THE TEAM**
- Degree or Diploma in a health and life sciences related field or equivalent combination of education and healthcare experience.
- Experience or related Healthcare work experience (in Drug/Medical Information, Medical Affairs, Regulatory Affairs, Clinical Trials or Healthcare call center environment).
- Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Global PV regulations, ICH guidelines and Pharmacovigilance auditing.
