Drug Safety Associate

4 weeks ago

Canada SetupmyHR Full time

Title: Drug Safety Associate


Role: Submission Specialist


Education and Experience : Any life Sciences graduate with 3-4 years experience in Submissions case processing.

Key Competencies: Level-3 proficiency in English, Working knowledge of French preferable, Located in Canada preferably with PR/work permit.


Location: Canada(Remote)

Our Client: A leading Pharma CRO/Lifesciences organization


NOTE: Only shortlisted candidates with legal authorization to work in Canada and the educational qualification mentioned will be contacted.


Brief Description of Duties:

• Play an integral role in the management of daily operational activities of the Global Submissions Team within Case processing.

• Responsible for managing the timely submission of Global ICSRs to various Health Authorities, License Partners, and CROs.

• Monitoring of Global submissions mailbox to address all the high-priority emails/ queries received from health authorities/ license partners related to ICSR submissions.

• Prepare local paper submissions to the US FDA in accordance with the Client’s processes

• Responsible for addressing 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's requirements.

• Monitoring the safety database for failed transmissions to resolve the issue on time.

• Involved in preparing safety ICSR submission package to Health Authorities as per the requirements.

• Follow up with the 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 the Regulatory Intelligence team, and Safety Data Management to maintain accurate reporting rules in the Safety Database.

• Responsible for configuring clinical studies in the database, reviewing clinical trial protocols, and configuring reporting rules as per regulations.

• As a Submissions SME, support local safety managers daily for all ICSR submission-related matters.

• Identifying root causes for late ICSR submissions and providing appropriate corrective and preventive actions to the 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.

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