Quality Controller (H/F)

Job Summary
The Quality Control Coordinator who is referred to as Drug Safety Mailbox Administrator reporting to the Manager, Drug Safety and Pharmacovigilance Operations 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 Patient Support Services 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
Manage Pharmacovigilance (PV) inbox and conduct follow ups as required.
Help set regarding emails as required.
Identify, triage, and route all incoming communication (internal and external) to the appropriate team members as per program/product assignment.
Assess date of awareness and assign due date of all incoming drug safety reports.
Assign safety cases to team members as per program/product alignment.
Review safety source documents and conduct follow-up for additional information from the initial reporter and fill in gaps as necessary.
Assist the Drug Safety and Medical Information (DSMI) team with CRM data entry as needed.
Assist the DSMI team with other Pharmacovigilance related duties as needed.
Support with PV audit requests.
Build excellent rapport with the internal and external customers.
Complete other departmental tasks as assigned.
Maintains confidentiality of patient, client, and corporate information at all times.
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.
Adheres to Bayshore’s Policies and Procedures.
Qualifications

EDUCATION

Experience
~ Experience working with data entry portals and applications an asset.

Other Skills And Abilities
Knowledge of local Pharmacovigilance requirements and principles.
Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products.
Excellent written and verbal communication skills.
Excellent organizational skills and attention to detail.
Flexible, adaptable, and able to work under pressure.
Demonstrated initiative and accountability and be able to work under minimal supervision.
Excellent customer service skills – ability to handle internal and external stakeholder queries.
Team Player with ability to function in a multi-disciplinary environment and promote collaboration.
Proficiency with Microsoft Office suite (Outlook, Word, Excel and PowerPoint).
Bilingual (English/French) is an asset.
Primary Location
ON-Markham