Bilingual Pharmacovigilance Specialist
Bayshore
Mississauga, Ontario, Canada
6d ago

Job Summary

Reporting to the Pharmacovigilance Lead, the Bilingual Pharmacovigilance Specialist is responsible for managing the collection, processing and reporting of Adverse Events (AEs) for the Patient Support Program.

He / she will also ensure compliance with National and Global Pharmacovigilance requirements, represent the Pharmacovigilance (PV) Department at Bayshore meetings both internally and externally as needed, and assist with all audits.

Duties and Responsibilities

  • Review PV reports from both Single Point of Contacts , Reimbursement Specialists and Pharmacy Team for accuracy
  • Enter all PV reporting into CRM as directed
  • Forward PV reports to Drug safety
  • Help develop and implement CAPAs to ensure compliance with program requirements
  • Complete QMRs for late PV reporting
  • Report and document Adverse Events as per Pharmacovigilance requirements
  • Assist with updating internal PV policies, SOPS and work instructions as needed
  • Attend / Dial Into weekly meetings with the Liaison Patient Support Program team
  • Assist with delivering program specific AE / PV training to new members of the team
  • Collaborate and interact with Pharmacovigilance team regarding new initiatives, requests for SOPs, difficult cases or Best Practices
  • Complete daily Kroll and CRM audits with assistance from the PV Specialist
  • Complete document submission for monthly client requests
  • Reconcile outstanding information relevant to Adverse Event reporting
  • Employee will maintain relevant level of knowledge of ICH (International Conference on Harmonization), GCP (Good Clinical Practice) and Health Canada GVP (Good Pharmocovigilance Practices) guidelines appropriate to their hired role which is to be provided at time of hire and annually.
  • With this knowledge the employee will perform the work as required by their assigned function and will be provided with regular updates as required.

  • Participate in processes relating to regulatory reporting requirements
  • Complete other tasks as requested
  • Experience

    Knowledge of Pharmocovigilance processes and Health Canada Pharmocovigilance regulations and guidelines

  • Excellent written, verbal, and facilitation skills
  • Excellent organizational & critical thinking skills and strong and proven attention to detail
  • Ability to work with strict timelines and handle multiple priorities
  • Flexible, adaptable and able to work under pressure and convey a sense of urgency
  • Demonstrated initiative and accountability
  • Excellent customer service skills to deal with client questions, sometimes under difficult circumstances
  • Team Player with ability to function in a multi-disciplinary environment and promote collaboration
  • Proficiency with standard desktop computing programs (e-mail, Microsoft Office, etc) and relational databases.
  • Prior experience with Pharmacovigilance reporting software and / or safety databases applications is an asset.
  • Bilingualism with French and English is a requirement in this position.
  • Other Information

    This is a working from home position.

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