- Entry level
- No Education
- Salary to negotiate
Janssen Pharmaceuticals, Companies of Johnson &Johnson is recruiting for Manager, Drug Safety & Surveillance, located atthe Head office in Toronto.
At Janssen, we are dedicated to addressing andsolving some of the most important unmet medical needs of our time in oncology,immunology, neuroscience, infectious diseases and vaccines, metabolic andchronic diseases and women’s health. Passionate about our dedication topatients, we bring innovative products, services and solutions to peoplethroughout the world. Janssen Inc. is a member of the Janssen PharmaceuticalCompanies of Johnson & Johnson. Please visit www.janssen.ca for more information.
As the Manager, DrugSafety & Surveillance (DSS) you will be responsible for leading, coachingand oversight of the Drug Safety team members. You will closely collaboratewith DSS Management Team, Global Medical Safety (GMS), business partners andthird parties in order to ensure maximum compliance with regulatory and Janssen’s global and localpharmacovigilance (PV) standards. You will lead/oversee projects aligned with the departmental objectives, includingtechnology innovation projects. You will contribute to business results bydriving deliverables and ensuring efficiencies related to the DSS function.
- Lead the DSSteam in alignment with the DSS strategic objectives.
- As a memberof the DSS Management team, participate in development an implementation of theDSS strategy.
- Ensure that the PVactivities are managed in compliance with local regulations and companypolices/procedures, and in accordance with any PV agreements with third partybusiness partners.
- Ensure that PV controlleddocuments and contractual agreements are in alignment with local regulationsand company polices/procedures.
- Partner with GMS and business teams to ensure alignment with global/business strategy, operational standards and inclusion of Canadian PV requirements, as applicable.
- Lead and/or support local and/or global projects in alignment with the DSS Plan
- Lead and/or support local and/or global PV system updates/upgrades, as applicable
- Drive innovation and technological advancements to ensure operational excellence
- Accountable for people management including monitoring workload and identifying resource needs/allocations.
- Demonstrate accountability for talent through leadership in the areas of recruiting, developing and retaining talent.
- Oversee team’s activities to ensure timely and accurate completion of assigned tasks
- Train internal and external personnel (e.g. vendors) on PV requirements, as needed
- Lead and/or support vendor management activities, as applicable.
- In collaboration with the DSS Management team, lead/support internal and external PV audits and related activities, as applicable.
- Create, track and complete corrective and preventative actions (CAPA) related to non-compliance, as applicable.
- University degree in Pharmacy, Nursing or other Canadian-equivalent Medical degree in a healthcare discipline is required.
- Minimum 8 years of pharmaceutical industry/clinical practice experience, with a minimum of 5 years of pharmacovigilance experience is required
- Extensive knowledge and experience in drug safety processing/reporting and regulatory compliance regulations is required
- Strong knowledge/experience with pharmacovigilance databases and medical terminology is required
- Previous supervisory/management experience is highly desirable with the ability to manage and develop people/teams
- Excellent communication and technical skills with a strong customer focus acumen
- Strong prioritization and organization skills with confirmed ability to respond with a sense of urgency and meet timelines
- 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 ofthe shared culture across the Johnson & Johnson Family of Companies.Attracting, developing and retaining a workforce that reflects the diversity ofour customers and communities is essential to our success. We are committed toproviding a respectful, inclusive and accessible work environment where allemployees have the opportunity to achieve their potential.
Janssen Inc. (7710)
Drug & Product Safety Operations
- microsoft excel
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.