Johnson & Johnson Careers
Drug Safety Associate
Requisition ID: 8547190701
Janssen Pharmaceuticals, Companies of Johnson & Johnson is recruiting for a Drug Safety Associate, located at the Head office in Toronto.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Passionate about our dedication to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visitfor more information.
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. This position will have an emphasis on conducting follow-up activities related to the ADRs as a major responsibility. You will also provide safety reporting training to internal client groups and third-party vendors and participate in special projects as assigned.
- 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.
- 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.
- Provide adverse event report including follow-up training to J & J employees and vendors as required and train DSS team members as assigned.
- University degree in Pharmacy, Nursing or other Canadian-equivalent Medical degree in a healthcare discipline is required.
- Minimum of a one-year experience in clinical practice or pharmaceutical industry is required
- Prior work experience with Pharmacovigilance database is an asset
- Good knowledge of medical terminology is required
- Good 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
- Proficient skill level in Adobe Acrobat, Microsoft Word is required. Advanced skills in Microsoft Excel is critical
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 have the opportunity to achieve their potential.
Janssen Inc. (7710)
Drug & Product Safety Operations