Patient Safety Manager

Patient Safety Manager

**Category**:Clinical Development and Medical**Location**:Mississauga, Ontario, CA- Does your motivation come from challenges and working in a dynamic environment? Do you want to play a key role in ensuring highest safety and lowest possible risk to patients who use Novo Nordisk products? Do you have a can-do attitude with continuous improvement as one of your career objectives?**PURPOSE**
- Responsible for affiliate pharmacovigilance procedures and systems for authorized and investigational products, to meet Canadian regulatory and local and global pharmacovigilance requirements. Manages the Canada Patient Safety staff ensuring compliance with Health Canada Regulations.**ESSENTIAL FUNCTIONS**
- Ability to perform all responsibilities of more junior Canada Patient Safety staff, including but not limited to:
- Perform workflow allocation and oversight, and if assistance for Patient Safety staff is needed, receives and documents domestic safety information, triages and prioritizes incoming cases according to internal and external requirements.
- Assesses incoming reports for seriousness, validity, listedness
- Inputs accurate data into the global receipt database database in compliance with internal as well as external requirements.
- Handle escalation calls from HCPs and consumers.
- If needed, assist Patient Safety staff with follows up with healthcare professionals and consumers.
- Interfaces with Global Safety to assure compliance with company policies and regulatory standard.
- Provides expert assistance to Patient Safety colleagues and colleagues in other departments in relation to safety activities and Health Canada pharmacovigilance regulations and requirements.
- Evaluates domestic and foreign ICSRs for expedited submission to Health Canada where electronic submissions by Safety Operations is not available.
- Performs Quality Check of Health Canada ICSR electronic submissions by Safety Operations as per internal procedures.
- Delegate to Associate Director in partnering with Global Safety, Medical Affairs, Clinical Operations, and Marketing locally to ensure that all affiliate activities (e.g. ISS, local clinical trial, patient support programs and market research) are included in the Novo Nordisk Pharmacovigilance System Master File and covered by pharmacovigilance agreements and/or protocols.
- Develops and delivers employee & external vendor pharmacovigilance training on safety reporting.
- Participates in Health Canada and internal audits and inspections to support continuous compliance with internal guidelines and federal regulations.
- Supports the maintenance of local Patient Safety Standard Operating Procedures (SOPs), manual(s) and work instructions.
- Support Safety management to keeps abreast of regulatory environment and healthcare changes that affect patient safety.
- Manages the quality control of customer interactions by reviewing customer interactions (written as well as verbal) completed by internal and third-party service providers, ensuring the quality of interactions in order to minimize errors in the transmission of reports to internal customers and health authorities
- Maintains up to date knowledge of the regulations and guidelines issued by Health Canada and ICH.
- Coaches and Develops Patient Safety staff and contingency workers.
- Represents Novo Nordisk Canada in Global Pharmacovigilance meetings and forums.
- Performs local literature screening and Health Canada vigilance database screening as needed.
- Performs QC of outsourced local literature screening and Health Canada vigilance database screening if needed.
- Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and lead implementation of solutions
- Serve as member of the Patient Safety Management team
- Contributes to NAO Patient Safety strategic planning
- Complies with Novo Nordisk policies, procedures, vision, and fundamentals.
- Assigns tasks to Patient Safety staff and performs certain tasks as assigned by management.

**DEVELOPMENT OF PEOPLE**
- Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
- Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

**QUALIFICATIONS**

**Education and Certifications**:

- Bachelor of Science degree in regulated healthcare professional field required
- People management experience preferred

**Work Experience**:

- Licensed healthcare professional with patient care experience
- 4 years Pharmacovigilance experience required
- People managemen