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Global Pharmacovigilance System

1 month ago


Montreal, Quebec, Canada Pharmascience Full time

At Pharmascience, we are seeking a highly skilled Global Pharmacovigilance System & Project Lead to join our team. This role is responsible for participating in the quality planning of the pharmacovigilance (PV) system, ensuring compliance with Canadian and international health authorities and global PV good practices.

Key Responsibilities:

  • Plan, monitor, and coordinate global PV activities to ensure compliance with deadlines and health authority requirements.
  • Actively monitor health authority regulations and guidelines for any changes or updates that may impact PV activities.
  • Prepare, negotiate, and maintain SDEAs with partners and PV service agreements.
  • Develop and maintain the Pharmacovigilance System Master File (PSMF), PV System Summaries, and contact information for global and local Qualified Persons Responsible for Pharmacovigilance (QPPV).
  • Train team on PSMF and global requirements on an ongoing basis.
  • Ensure continuous readiness for internal audits and inspections.
  • Contribute to the production and distribution of case lists, summary tables, and/or metric reports for department management, partners, and others, as required.
  • Participate in various reconciliation activities with various company departments, partners, and others, as required.
  • Track compliance and metrics through reporting, corrective and preventive actions (CAPA), and trending.
  • Contribute to and support all aspects of internal and external audits/inspections, including the creation and maintenance of audit-ready training files, as well as CAPA tracking and resolution.
  • Establish, update, and apply standard operating procedures (SOPs) and local work instructions (WIs) to ensure compliance with international and national pharmacovigilance requirements.

PV Database Maintenance:

  • Configure and maintain PV database and security parameters.
  • Maintain and update required information in PV database.
  • Assist management in the creation and generation of reports and queries in the PV database.
  • Assist management in the operationalization of business rules in the PV database.
  • Train/coach colleagues on the correct use of the PV database.
  • Lead PV database validation and implementation activities.
  • Lead the validation and implementation activities of the computerized PV system, E2B electronic submissions, as well as any other safety and system-related projects.

Requirements:

  • In-depth knowledge of regulatory requirements for adverse reaction reporting and PV activities.
  • Excellent computer skills (MS Office).
  • Excellent verbal and written communication skills.
  • Bilingualism in French and English.
  • Excellent prioritization and organizational skills.
  • Strong teamwork skills.
  • Attention to detail and quality of work.
  • Constant concern for process improvement.
  • Strong work ethic.
  • Positive attitude and self-reliance.
  • Experience and knowledge of Canadian, US (FDA), and European PV regulations and pharmacovigilance best practices.
  • Experience of PV operations and systems.
  • Experience in writing and reviewing PV-related documents (PSUR, RMP, SDEA, PSMF, etc.).
  • Experience with EudraVigilance (asset).

What We Offer:

  • Being part of a great, collaborative, and dedicated team that strives for continuous improvement.
  • Being part of a corporate culture that values entrepreneurship, teamwork, simplicity, and going above and beyond.
  • A flexible schedule with a hybrid work model: 3 days/week working remotely at the employee's choice.
  • Access to a full range of benefits, including telemedicine as of day 1.
  • Access to RRSP with employer contribution as of day 1.
  • Enjoying our on-site gym and training classes for free.
  • Being involved in the community.