Job Description

Janssen Inc., is seeking a Drug Safety Associate (Bilingual) in Toronto, ON.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Inc., is part of the Janssen Pharmaceutical Companies.

The drug safety associate is responsible for all stages of domestic and foreign adverse event reporting for assigned clinical study and post-marketing products. Collects data regarding adverse events. Reviews and determines regulatory reporting requirements based on assessment of seriousness, causality and expectedness/listedness against Health Authority guidelines and product labeling. Prepares adverse events reports for submission to Health Canada within the appropriate reporting timeframes. Verifies accuracy, completeness, and validity of report information. Applies clinical judgment when interacting with healthcare professionals and consumers to obtain and follow up on reports of possible adverse events.

At this level, participation in activities aligned with the departmental and corporate business objectives is encouraged. May participate in inspection/audit readiness activities such as the Health Canada GVP Inspection. Assists in the review and implementation of training and cases processing procedural documents.

Provides safety reporting training to third-party vendors (market research, patient assistance providers) with manager\'s oversight. May be assigned to projects aligned with the area of responsibility and the developmental goals.

Key Responsibilities:

• Evaluate adverse event reports, assess regulatory status (seriousness and expectedness/relatedness) to prioritize workload.
• Prioritize workload for assigned products and liaises with other Safety and Compliance Associates to ensure on time processing.
• Process adverse event reports from spontaneous sources, clinical trials, studies and marketing activities (including healthcare professionals and consumers) in accordance with company standard operating procedures (SOP) and guidelines for maintaining regulatory compliance.
• Perform domestic and foreign case assessment for Health Canada reporting
• Request product complaint investigation (e.g. PQC number) on appropriate cases according to the SOP.
• Determine and conduct follow-up actions as required with appropriate communication methods (e.g. fax, email, telephone).
• Participate and may lead team discussion for both case processing and scientific product knowledge.
• Provide coverage to all products/devices as assigned.
• Respond to GMS and international affiliates as required for operational (e.g. queries), compliance and/or safety functions.
• Provide adverse event report training to J & J employees and vendors as required.
• Train Drug Safety team members as assigned.
• Participate in special projects as assigned.
• May cover other duties as assigned

Education:

• University Degree in in Pharmacy/Nursing/Medicine/Dentistry or the Canadian equivalent

Required:

• Effective written and oral communication skills in English and French
• At least 1 year in clinical practice and in pharmacovigilance or pharmaceutical industry
• Basic knowledge of medical terminology
• Good understanding of safety regulations
• General working knowledge of document management systems
• Proficient skill level in Adobe Acrobat, Microsoft Word, and Excel
• Prioritization and organization of workflow activities to meet tight deadlines
• Superior level of attention to detail
• Ability to work in a team environment
• Excellent problem-solving abilities

Preferred

• High proficiency in Microsoft Excel
• Good understanding of Health Canada regulations
• Prior work experience with Pharmacovigilance database

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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