Pharmacovigilance Compliance Associate

Janssen Inc., Canada is currently recruiting for a Pharmacovigilance Compliance Associate in Toronto ON. 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. 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 Research & Development, LLC is part of the Janssen Pharmaceutical Companies. The Pharmacovigilance Compliance Associate will collaborate and lead safety compliance surveillance activities for the Drug Safety and Surveillance (DSS) Department in Canada, such as metric assessments related to on time adverse events reporting to Internal and External Partners and Health Authorities and manage Canadian pharmacovigilance (PV) nonconformances. Lead/support quality assessments of the departmental Pharmacovigilance (PV) activities to ensure consistency in all high priority areas of PV data management, including but not limited to quality check review of PV data intake, case processing and submission to Health Authorities Pharmacovigilance Compliance Associate Major Duties & Responsibilities: DSS Compliance Monitoring activities as compliance analyses and trends, tracking, documentation and archiving of compliance related documentation records: Daily/weekly/monthly oversight of compliance data that comes from various sources: LabCorp, BioAdvance, Commercial Quality, Global PV and etc. It includes any notification from other DSS groups of possible boluses of late cases, other updates (i.e. Off-Label-Use cases, global boluses, updates etc.) that may potentially impact compliance. Lead mitigation of any risks for compliance, initiate collaboration with other teams and propose an additional training to affected groups as needed. Document/inform any affected parties (locally and globally) of compliance non-conformances. Ensure tracking of any documents in the local DSS compliance repository. Lead and support the investigation and documentation management PV Quality Investigations (QIs) Lead and support the investigation and documentation management of Deviation Memo (DM) records Ownership and oversight of compliance impact for DSS Department in respect to the DSS responsibility of completing Monthly Case Receipt and Regulatory reconciliation combine, with the next one, and add details (mostly related to compliance on inbound and outbound reports) Lead/Support PV Compliance Activities In collaboration with the applicable groups, support the completion PV assessments for the purposes of supplier approva Inspection/Audit Readiness support Lead/support other duties as listed, but not limited to: Local controlled documents creation, review, revision, update Generate compliance data for external business partners as required Qualifications Qualifications Minimum University Degree in Pharmacy/Nursing/Medicine/Dentistry or Bachelor of Science degree (or the Canadian equivalent). Minimum 4 years of Clinical or Pharma/BioPharma industry experience and minimum of 2 years of Pharmacovigilance Compliance experience Experience in Quality Issues management is preferred Quality Management Systems is preferred Advanced skills for planning, organizing, and collaborating with internal and external partners to achieve tasks with high business priority Strong understanding of safety regulations, compliance requirements, project management planning, data tracking and compliance summaries Demonstrated knowledge of case assessments, case processing in the Global Safety System, reportability determination and reporting to Health Authorities General working knowledge of document management systems Proficient skill level in Adobe Acrobat, Microsoft Word and Microsoft Excel Prioritization and organization of workflow activities to meet tight deadlines Work / Other Head office in Toronto flex schedule office (min 3 days onsite) Requirement for long periods of sustained visual focus and concentration Expectation to use a computer on an almost continuous basis, every day Janssen Inc. is based in Toronto, Ontario and supports a Flexible Work Arrangement to provide flexibility options for individual needs to support when, where and how we work. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 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. Primary Location Canada-Ontario-Toronto-19 Green Belt Drive Organization Janssen Inc. (7710) Job Function R&D Requisition ID 2206064341W