Product Safety Analyst (Contract 8 months)
Location: (this position can be remote)
At Novo Nordisk Canada, we offer an extensive employee development plan in order to attract and retain the best employees. We have a robust recruitment process in place to ensure that we hire people who are ambitious and driven and will fit well in our friendly team culture. In our culture, everyone’s opinion is valued and respected. In return, we ask our employees to be ambitious with their goals and strive for excellence. In short, we work with you to develop your life-changing career.
This is a full-time contract opportunity. that will be responsible for supporting the Product Safety Specialist and qualified person responsible in Pharmacovigilance ensuring that the Pharmacovigilance system is compliant with Corporate and Regulatory requirements.
Key Areas of Responsibility:
• Receives, and documents domestic safety information, triages and prioritizes incoming cases according to internal and external requirements.
• Assesses cases for seriousness, validity, listedness and causality.
- Inputs accurate data into the safety database in compliance with internal as well as external requirements.
• Follows up with healthcare professionals and consumers (by letter, questionnaires, email, phone contact, etc) to obtain relevant medical information pertinent to case analysis and signal detection.
• Monitors status of adverse event reports (responding to queries from Global Safety; monitoring completion of follow-ups, etc.) to ensure cases are completed within the required timeframe.
• Delivers employee training on safety reporting
• Evaluates domestic and foreign ICSRs for expedited submission to Health Canada.
• Reconciles adverse events reports.
• Works closely with Product Safety Specialist and/or Qualified Person Responsible for Pharmacovigilance and provide back-up in their absence.
• Supports Product Safety Specialist and/or Qualified Person Responsible for Pharmacovigilance in investigation, root cause, corrective and preventive actions related to internal and external PV associated CAPA findings
• Establishes, maintains, and improves the affiliate safety system to receive, record, report and archive NNCI investigational, authorized product and device safety information.
• Supports maintenance and administration of local system applications supporting pharmacovigilance (e.g. GSSaes, Health Canada e-reporting, CCGloW Superuser, SAE tracker)
• Monitors dedicated Product Safety email accounts and generates compliance report to Global Safety.
• Supports preparation, distribution, and tracking of compliance reports, safety reports/information requested by internal customers/external customers.
• Supports the maintenance of local Product Safety Standard Operating Procedures (SOPs), manual(s) and work instructions.
Skills and Qualifications:
- Bachelor of Science degree as a minimal with a preference for a science degree in regulated healthcare professional field
- Must have a HCP designation
- School/certification related to Pharmacovigilance
- Basic computer knowledge and computer keyboarding skills
- Computer data entry experience
- Excellent attention to detail
- Strong verbal, written and interpersonal communication skills
- Strong organization and prioritization skills, able to multitask
- Ability to work independently and within a team environment
- Familiar with Microsoft Office Suite (Outlook, Word, Excel)
- Experience working with safety databases and pharmaceutical industry
- Bilingual French/English is preferred
Internal Application Deadline: February 17, 2021
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please email us at [email protected] (This contact is for accommodation requests only and cannot be used to inquire about the status of applications as they will not be responded to).
Please note: We thank all applicants, however only candidates being considered for an interview, will be contacted.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.