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Manager, Drug Safety & Surveillance (Contract)
Requisition ID: 3296180208
Janssen Pharmaceutical, companies of Johnson & Johnson is hiring a Manager, Drug Safety & Surveillance (contract) located in Toronto, Ontario.
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. Driven by our commitment 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 visit www.janssen.ca for more information.
As the Manager, Drug Safety & Surveillance you will be responsible for leading, coaching and oversight of the Drug Safety team members. You will collaborate with Global Medical Safety (GMS), business partners & third parties to clarify procedures, provide input and ensure compliance. Manage the monthly reconciliation process with Global Medical Safety & periodic reconciliation with Health Canada. Monitor compliance to Health Canada and GMS, identifies areas for improvement and communicates this with management and the Drug Safety team. Lead projects aligned with the departmental objectives including technology projects and innovation teams. Contribute to business results by driving timelines and deliverables related to the DSS function. Perform safety assessment and follow up tasks as required.
Your core responsibilities will be:
- Provide oversight to compliance activities including but not limited to: adverse event intake, initial triage, prioritization of reports based on seriousness, case file tracking, case entry, follow up as required and submission of cases to Health Canada and affiliates in compliance with regulations, company SOPs and Pharmacovigilance agreements
- People Leader responsibilities such as recruitment, goal setting, talent development, ongoing coaching
- Manage assigned team members in their daily activities. Supervises and instructs direct reports regarding PV activities to ensure timely and accurate completion of assigned tasks
- Create and tracks corrective and preventative actions (CAPA) related to non-compliance
- Perform periodic case quality check reviews and communicates results to management and the drug safety team
- Monitor workload and identifies resource needs/allocations to ensure the appropriate functioning of the DSS Department
- Train internal and external personnel (e.g. vendors) on PV requirements as needed
- Provide ad hoc support for safety related queries as required
- Departmental document management in collaboration with management team
- Support internal and external compliance audits in collaboration with departmental management
- Lead and/or support local, global projects which are aligned to the DSS Plan
- Lead and/or support local, global pharmacovigilance system updates/upgrades and related change management, as applicable
- Support vendor management activities
- University degree in Pharmacy or Nursing; Medical degree or the equivalent
- Healthcare professional background including but not limited to, pharmacist, nurse, medical doctor or dentist
- Experience should include at least 8 years in pharmaceutical industry or clinical practice and/or a minimum of 5 years of drug safety related experience
- Previous supervisory or management experience is highly desirable with the ability to manage and develop people/teams
- Extensive knowledge and experience with safety processing, regulatory compliance, clinical study and spontaneous safety reporting is required
- Excellent understanding of process, training in process excellence is an asset
- Strong knowledge of pharmacovigilance databases and good knowledge of medical terminology is required
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