JOB SUMMARY

The Senior Manager, Drug Safety and Pharmacovigilance Operations is responsible for overseeing the end-to-end operational management of the Drug Safety and Medical Information (DSMI) department. This role provides leadership to Managers and Team Leads and ensures the timely, compliant, and efficient delivery of pharmacovigilance services across all client programs. The Senior Manager will manage case processing activities, resource allocation, vendor oversight, client engagement, and ensure continuous alignment with Health Canada and global PV regulations. Reporting to the Director of Pharmacovigilance, this position plays a key leadership role in operational strategy, performance excellence, and cross-functional collaboration.

QUALIFICATIONS

Education:

• Graduate or graduate discipline in a relevant field (e.g., life sciences, healthcare, regulatory affairs, business, or law).

Experience:

• Minimum 7 years of pharmacovigilance or drug safety experience, including 3+ years in a leadership role.
• Strong knowledge of Health Canada and global PV regulations (e.g., GVP, GCP, ICH guidelines).
• Proven ability to manage large teams and multiple PV programs concurrently.
• Experience with vendor oversight, client communications, and case management systems.
• Strong project management, organizational, and communication skills.
• Demonstrated ability to interpret and integrate policies and procedures.
• Proven track record in conducting adult education initiatives and project management.
• Strong time management skills and ability to evaluate urgent situations and make appropriate decisions.
• Excellent communication skills.
• Valid driver’s license and willingness to undertake out-of-town travel as required.
• Working knowledge of the French language is an asset.

Other Skills and Abilities

• Strategic thinker with ability to lead operational planning and execution.
• Experienced in performance management, resource planning, and departmental growth.
• Knowledge of CRM, safety databases, and compliance systems.
• Bilingualism (English/French) is an asset.

Operational Leadership:

• Provide strategic and day-to-day leadership across all PV programs and operations.
• Oversee all PV Managers and Team Leads, ensuring accountability, performance, and consistency in delivery.
• Monitor case processing, timelines, and reporting requirements to ensure regulatory compliance.
• Optimize workflow processes, databases, and tools to support efficient AE, PQC, and MI handling.
• Collaborate with internal stakeholders to manage vendor and client expectations and deliverables.
• Complete other tasks as requested.

Client Management:

• Act as the main point of escalation for client operational concerns across PV programs.
• Support Managers in client meetings and communications; intervene in complex or urgent matters.
• Manage client relationships, ensuring quality, compliance, and timely deliverables.
• Assist in budget planning, forecasting, and billing oversight for PV services.
• Complete other tasks as requested.

Resource Allocation & Team Oversight:

• Direct department-wide resource planning, including float team coordination in partnership with National Lead, PV Compliance and Process Improvement.
• Approve staff allocation across programs based on business needs and client volumes.
• Collaborate with the National Lead, PV Compliance & Process Improvement on onboarding, training, and re-integration of staff returning from leave.
• Complete other tasks as requested

Continuous Improvement & Strategy

• Identify operational bottlenecks and recommend improvements to enhance service delivery.
• Monitor KPIs, resource utilization, and client satisfaction, implementing corrective actions as needed.
• Partner with National Lead, PV Compliance and Process Improvement to align operations with SOPs, regulatory updates, and audit readiness.
• Complete other tasks as requested.

Employee Development & Training:

• In collaboration with HR, you will be responsible for overseeing recruitment, training, and performance management initiatives, as well as driving employee development efforts and other responsibilities within the people operations function.
• Foster a positive, collaborative culture that supports compliance, accountability, and staff development.
• Ensure adherence to government, company, and ISO 9001-2000 standards for high-quality service delivery.
• Ensure team performance aligns with organizational goals and regulatory standards.
• Complete other tasks as requested.

Qualifications: