Global Pharmacovigilance System & Project Lead

A leader in the generic pharmaceutical industry, the Pharmascience team is made up of 1,500 people involved in the production and marketing of generic prescription, over-the-counter and pharmacist-dispensed drugs, as well as injectable medicines, all manufactured in Canada.

Pharmascience is a privately-held, full-service pharmaceutical company with deep roots in Canada and a growing global reach, including distribution in over 50 countries.

Joining Pharmascience means joining a Canadian leader in the generic pharmaceutical industry, with a growing global reach. Every year, our commitment to our employees is recognized. Among our recent awards: The Career Directory 2024, Great Place to Work 2024, Best WorkplacesTM with the Most Trusted Leadership Teams 2024, Best WorkplacesTM in Healthcare 2024 and Best Workplaces for Community Involvement 2023.

Summary

The Global Pharmacovigilance System & Project Lead is responsible for participating in the quality planning of the pharmacovigilance (PV) system, participating in its compliance, control and improvement, ensuring the compliance of the PV system and activities with the requirements of Canadian and international health authorities and with global PV good practices as well as planning, monitor and coordinate global PV activities, processes and projects, including Periodic Safety Reports (PSRs), Risk Management Plans (RMPs), Safety Data Exchange Agreements (SDEAs), follow-up activities, etc.In addition, he/she must establish and maintain the PV system, including the creation and updating of documents and information as required, ensure the maintenance of the PV database and its safety parameters, and ensure overall compliance management and key performance indicator (KPI) measurements. Finally, the Manager will perform routine activities to assist the Pharmacovigilance team as required.

Responsibilities & tasks

Global PV activities:

• Plan, monitor and coordinate global PV activities to ensure compliance with deadlines and health authority requirements (e.g. PSRs, RMPs, compliance monitoring, SOP/WI, PV and non-PV employee training, SDEA, etc.).
• 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.
  Create and maintain the department's electronic and paper filing system at all times.
• 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.
• Support the Pharmacovigilance and Medical Information Manager as required.

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.

Skills, knowledge & abilities

• 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 & 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)

Choosing Pharmascience also means

• 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
• Having a flexible schedule with a hybrid work model: 3 days/week working remotely at the employee’s choice
• Accessing to a full range of benefits including telemedicine as of day 1
• Accessing to RRSP with employer contribution as of day 1
• Enjoying our on-site gym and training classes for free
• Being involved in the community