Pharmacovigilance Operations Intern

The Pharmacovigilance Operations Intern will assist in the receipt, processing, reporting, and management of Individual Case Safety Reports (ICSRs) in compliance with applicable regulation, the company's Standard Operating Procedures, and project-specific operational agreements. The role will also provide administrative support for the department. 

Location: office based in Dundas, Canada

Responsibilities and Accountabilities include:

• Prioritizing and managing multiple projects within established time frames

• Monitoring and managing project-specific e-mail accounts, incoming faxes and telephone calls. Preliminary triaging of ICSRs to determine classification, priorities and time frames for subsequent activities. 

• Entering source information for ICSRs into safety databases, tracking systems and/or projects-specific report forms ensuring accurate data-entry. 

• Assisting with contacting reporters of ICSRs to collect additional information, supporting documents and answers to queries within pre-defined parameters.

• Assisting with submission of ICSRs to regulatory agencies, clients or client partners in accordance with pre-determined documented distribution rules. This may include submissions by fax, email, courier or E2B

• Tracking ICSR activities, ensuring that ICSR activities are complete and that ICSR files contain all relevant documentation

• Assisting with reconciliation of safety databases, safety tracking systems, medical information databases, product complaint databases and clinical databases

• Maintaining pharmacovigilance files and archives in paper and electronic formats

• Completed Life Science degree (e.g BSc, RN, MSc, PharmD) 

• Sound written and oral communication skills

• Good organisational and planning skills

• Strong computer skills, working knowledge of safety databases preferred

• Ability to build positive, productive relationships with colleagues and clients

• Proficient in oral and written English #LI-AA1