Janssen Pharmaceuticals, Companies of Johnson & Johnson is recruiting for Manager, Drug Safety & Surveillance, 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 visit www.janssen.ca for more information.
As the Manager, Drug Safety & Surveillance (DSS) you will be responsible for leading, coaching and oversight of the Drug Safety team members. You will closely collaborate with DSS Management Team, Global Medical Safety (GMS), business partners and third parties in order to ensure maximum compliance with regulatory and Janssen’s global and local pharmacovigilance (PV) standards. You will lead/oversee projects aligned with the departmental objectives, including technology innovation projects. You will contribute to business results by driving deliverables and ensuring efficiencies related to the DSS function.
- Lead the DSS team in alignment with the DSS strategic objectives.
- As a member of the DSS Management team, participate in development an implementation of the DSS strategy.
- Ensure that the PV activities are managed in compliance with local regulations and company polices/procedures, and in accordance with any PV agreements with third party business partners.
- Ensure that PV controlled documents and contractual agreements are in alignment with local regulations and 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
- Strong leadership skills with the ability to work with and motivate teams
- Strong communication skills with the ability to act as a DSS advocate and influence stakeholders
- Extensive knowledge and experience in drug safety processing/reporting and regulatory compliance regulations
- Strong knowledge/experience with pharmacovigilance databases and medical terminology
- Previous supervisory/management experience is highly desirable with the ability to manage and develop people/teams
- Proven project leadership skills with the ability to coordinate activities of multiple functions
- Strong prioritization and organizational skills with confirmed ability to respond with a sense of urgency and meet timelines
- Proficient skill level in Adobe Acrobat, Microsoft Word and Microsoft Excel
Janssen Inc. (7710)
Drug & Product Safety Operations