Drug Safety Submission Specialist - Toronto, Canada - Apcer Life Sciences

Description

• Responsible for managing timely submission of Global ICSRs to various Health Authorities, License Partners and CROs.
• Prepare local paper submissions to US FDA in accordance with Otsuka processes.
• Responsible to address daily worklist to complete submissions to all applicable reporting destinations.
• Generate, Review, and Transmit reports to all Global Health Authorities including but not limited to FDA European Agencies, Health Canada and various other Health Authorities.
• Timely submission of appropriate reports to global partners based on defined timelines as per the PVA.
• Responsible for timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country requirements.
• Monitoring the safety database for failed transmissions to resolve the issue in a timely manner.
• Involved in preparing safety ICSR submission package to Health Authorities as per the requirements.
• Followup with Case Processing team and Medical Reviewers to request appropriate case correction for timely submissions of reports.
• Provide training and support to newer members of the submission team.
• Collaborate with Regulatory Intelligence team, Safety Data Management to maintain accurate reporting rules in the Safety Database.
• Responsible for configuring clinical studies in the database, review clinical trial protocols and configure reporting rules as per regulations.
• As Submissions SME, support local safety managers on daily basis for all ICSR submission related matters.
• Identifying root cause for late ICSR submissions and to provide appropriate corrective and preventive actions to Compliance and Business Management team.
• Responsible for timely investigation, analysis, and action on health authority queries.
• Monitor and address weekly ICSR submission reconciliations with local safety managers.
• Assist the Global Pharmacovigilance team with various projects to enhance system performance.

• Vision care

• 8 hour shift
• Monday to Friday

• Bachelor's Degree (preferred)

• ICSR Submission: 2 years (required)