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Product Safety Specialist

Category:  Quality
Location: 

Mississauga, Ontario, CA

   

 Product Safety Specialist

Location: Mississauga, ON

 

The Product Safety Specialist is responsible for affiliate pharmacovigilance procedures and systems for authorized and investigational products, to meet Canadian regulatory and corporate requirements.

 

Key Areas of Responsibilities:

  • Receives, assesses, follows up, investigates, documents and files incoming Adverse Events (AE), incompliance with internal as well as external requirements

  • Interfaces with NNAS Global Safety to assure compliance with company policies and regulatory standard.

  • Provides expert assistance to colleagues in other departments in relation to safety activities.

  • Evaluates domestic and foreign ICSRs for expedited submission to Health Canada

  • Collaborates with Clinical Operations to ensure new safety information is communicated to investigators and ethics committees/IRB’s according to ICH GCP Guidance.

  • Establishes, maintains, and improves the affiliate safety system to receive, record, investigate, report and archive NNCI investigational, authorized product and device safety information.

  • Strategically partners with global safety, Medical Affairs, Clinical Operations, and Marketing 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 safety data exchange agreements and/or protocols.

  • Develops and delivers employee & external vendor training on safety reporting.

  • Responsible for the local quality system supporting pharmacovigilance.

  • Prepares and plans health authority, internal and vendor pharmacovigilance inspections in partnership with Quality.

  • Plans and owns local system applications supporting pharmacovigilance (e.g.GSSaes, Health Canada e-reporting, CCGloW Superuser, SAE tracker).

  • Contributes to local cross-functional planning & execution of annual, risk mitigation, and crisis or issue-related safety communications to patients, healthcare professionals, and Health Canada.

  • Maintains relationships with global safety and 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.

  • Coaches and Develops pharmacovigilance designated backup and contingency workers.

  • Represents Novo Nordisk Canada in Global Pharmacovigilance meetings and forums responsible for development, maintenance and delivery of training in Adverse Event reporting to all employees, e.g. at annual plan of action meetings.

  • Responds to external and internal inquiries on Novo Nordisk products.

  • Reviews standard medical information documents.

  • Contributes to strategic planning.

  • Monitors expenses within budget.

  • Complies with Novo Nordisk policies, procedures, vision and fundamentals.

  • Performs tasks as assigned by management

 

Education & Experience:

  • Bachelor of Science degree in regulated healthcare professional field.

  • Licensed healthcare professional with patient care experience.

  • Strong ability to communicate with patients and HCP (verbal & written).

  • Advanced analytical reasoning and problem-solving ability.

  • Self-motivated, strong interpersonal skills and works effectively across boundaries.

  • Proven ability to develop and lead continuous improvement.

  • Bilingual (English/French) is an asset.
     

We thank all applicants but only those being considered for an interview will be contacted

 

Internal Application Deadline: December 10, 2021

 

Novo Nordisk Canada Inc. requires all employees, both Field and Office-Based, to be fully vaccinated with a COVID-19 vaccine by November 15, 2021. Please confirm that you are fully vaccinated, are willing to be fully vaccinated prior to starting employment.

 

 Novo Nordisk is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or any other characteristic protected by Canadian laws, rules, or regulations.

 

 If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 905-206-2854. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.  Only candidate being considered for an interview will be contacted.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.