Job Description

Job Overview

Responsible for Medical Inquiry call handling and corresponding activities as a member of the medical information team. Additionally, perform tasks/responsibilities as assigned/delegated by the team lead/manager.

Responsible for the operations of the pharmacy including study drug accountability and return or disposition of all unused study product(s), in accordance with the study protocols, directives, SOPs, GCP and other applicable regulatory requirements. Also, responsible for other tasks including technical and non-technical as assigned.

Responsibilities

Medical Inquiry call handling and corresponding activities as a member of the medical information team. Ensure medical inquiry fax machine, phone and postages are checked on daily basis for Medical Inquiry/Adverse Events/Product Inquiries/Product Quality Complaints. Assist designated medical reviewer and safety team members for follow up of all medical inquiry. Perform additional tasks/responsibilities as assigned/delegated by the team lead/manager. Assisting with the preparation of the audit/inspection and participating in the audit/inspection when appropriate. Receiving, handling and accountability of study drug and managing all pharmacy associated documentation including drug destruction. Identify and address any discrepancies with the study drug, protocol and any accompanying documentation. Participate in training as required, maintain training records and read all the applicable SOPs and regulations in a timely manner with appropriate completed documentation. Overseeing environment monitoring in pharmacy and maintenance of cobalt. Additional tasks may also be assigned based on the training and qualifications (i.e. training, pharmacy tours etc.).

Qualifications

Use of relevant software packages in a windows environment (i.e. MS Word, Excel). Excellent verbal, written and interpersonal skills required. Must be able to accommodate a flexible work schedule. Industry and regulatory knowledge are a strong asset. Previous experience in clinical research is an asset. A minimum of a post-secondary degree in a science or healthcare related discipline.
Job Type: Full-time

Application question(s):

Are you a Canadian citizen, or Permanent Resident that holds a valid work permit?
Work Location: In person