Drug Safety Associate at Janssen
Janssen Pharmaceuticals, Companies of Johnson & Johnson is recruiting for a Drug Safety Associate, for a 12-month fix term contract, located at the Head office in Toronto.
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. Most importantly 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 a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
To begin with, As a Drug Safety Associate, you are responsible for all stages of domestic and foreign adverse event reporting for assigned clinical study and post-marketing products. This includes collecting data regarding adverse events, reviewing and determining regulatory reporting requirements and preparing adverse events reports (ADRs) for submission to Health Canada. Also, This position will have an emphasis on supporting drug safety operations including conducting follow-up activities related to the ADRs. You will also generate safety reports to internal client groups as well as third-party vendors and participate in special projects as assigned.
- Firstly, Determine and conduct follow-up actions as required with appropriate communication methods (e.g. fax, email, telephone).
- Apply clinical judgment when interacting with healthcare professionals and consumers to obtain and follow-up on reports of possible adverse events.
- Prioritize workload for assigned products and liaise with other Safety and Compliance Associates to ensure timely processing.
- Subsequently evaluate and prepare adverse event reports; Review and determine regulatory reporting requirements based on assessment of seriousness, causality and expectedness in accordance with regulatory guidelines and product labeling.
- 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.
- Request product complaint investigation (e.g. PQMS number) on appropriate cases according to the SOP.
- Participate and may lead team discussion for both case processing (including follow-up activities) and scientific product knowledge.
- Furthermore, provide adverse event report including follow-up training to J & J employees and vendors as required and train DSS team members as assigned.
- Holds a university degree in Pharmacy, Nursing or other Canadian-equivalent Medical degree in a healthcare discipline
- Minimum of a one-year experience in clinical practice or pharmaceutical industry
- Prior work experience with Pharmacovigilance database is an asset
- Good knowledge of medical terminology is required
- Proper understanding of safety regulations
- General working knowledge of document management systems
- Strong prioritization and organization skills with confirmed ability to respond with a sense of urgency and meet timelines
- Excellent communication and writing skills combined with excellent problem-solving abilities
- High level of attention to accuracy and details
- Ability to work independently and in cross-functional team settings
- In addition, Proficient skill level in Adobe Acrobat, Microsoft Word is required. Advanced skills in Microsoft Excel is critical
However, Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Also, Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. In conclusion, We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
Canada-Ontario-Toronto-19 Green Belt Drive
Janssen Inc. (7710)
Application Closing: Not Specified.