Drug Safety Mailbox Admin

Summary

The Drug Safety Mailbox Administrator is responsible for primarily triaging and managing the Pharmacovigilance email inbox daily, ensuring timely and appropriate management of all communication received in the centralized PV mailbox.

The incumbent will represent the Scientific Affairs Department at Bayshore Specialty Rx, both internally and externally and be instrumental in ensuring compliance with Pharmacovigilance Contractual Obligations, Canadian Adverse Event reporting guidelines, Good Pharmacovigilance practices and Medical Information practices.

Duties And Responsibilities

• Help set regarding emails as required.
• Build excellent rapport with the internal and external customers.
• Review safety source documents and conduct follow-up for additional information from the initial reporter and fill in gaps as necessary.
• Support with PV audit requests.
• Assess date of awareness and assign due date of all incoming drug safety reports.
• Manage Centralized Pharmacovigilance (PV) Email Inbox and conduct follow ups as required.
• Identify, triage, and route all incoming safety communication (internal and external) to the appropriate drug safety team members as per program/product assignment.
• Assist the DSMI team with other Pharmacovigilance related duties as needed.
• Assist the Drug Safety and Medical Information (DSMI) team with CRM data entry as needed.
• Assign safety cases to team members as per program/product alignment.
• Complete other departmental tasks as assigned.

General Duties And Responsibilities

• Maintains confidentiality of patient, client, and corporate information at all times.
• Adheres to Bayshore’s Policies and Procedures.
• Employee will maintain relevant level of knowledge of GDP (Good Documentation Practices), Health Canada GVP (Good Pharmacovigilance Practices), Health Canada Adverse Event Reporting guidelines, as appropriate to their hired role which is to be provided at time of hire and on an as needed basis. With this knowledge the employee will perform the work as required by their assigned function and will be provided with regular updates as required.

Education

Minimum Requirements - High School Diploma or Post High School Certification or College Diploma.

Experience

• Knowledge of local Pharmacovigilance requirements and principles.
• Experience in Pharma or Healthcare setting.
• Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products.

Other Skills And Abilities

• Team Player with ability to function in a multi-disciplinary environment and promote collaboration.
• Flexible, adaptable, and able to work under pressure.
• Excellent customer service skills – ability to handle internal and external stakeholder queries.
• Demonstrated initiative and accountability and be able to work under minimal supervision.
• Proficiency with Microsoft Office suite (Outlook, Word, Excel and PowerPoint).
• Experience working with data entry portals and applications an asset.
• Excellent organizational skills and attention to detail.
• Excellent written and verbal communication skills.

Primary Location

ON-Mississauga