Manager Pharmacovigilance and Patient Safety

Job Description

The Manager Pharmacovigilance and Patient Safety provides strategic leadership and oversight of cross‑functional and outsourced activities supporting ICSR management and periodic safety reporting for Tolmar’s global pharmacovigilance (PV) program. This role ensures regulatory compliance, drives operational excellence across assigned products or therapeutic areas, and adapts responsibilities as required by evolving contractual obligations with marketing partners and vendors. The Manager will work with Tolmar QAPS Technical Complaints to provide medical oversight for safety investigations.

Essential Duties and Responsibilities

• Lead the Patient Safety team in overseeing and managing PV external service providers, including ICSR processing, literature monitoring, signal detection, medical writing, PSUR preparation, and onboarding of new products in the US and Canada.
• Evaluate, propose, and implement innovative, industry‑leading approaches to enhance surveillance, signal detection, and risk‑mitigation activities for marketed and developmental products.
• Support global PV operations in partnership with internal teams, business partners, and external vendors.
• Collaborate with internal PV experts and business partners to help with cross-functional decision making.
• Serve as a primary point of contact for PV vendors and/or business partners.
• Partner with internal functions (Regulatory, Clinical, QA, Legal) to fulfill safety-related information requests from Tolmar leadership and Health Authorities.
• Oversee ICSR and aggregate safety report management for business partners and contracted service providers.
• Collaborate with outsourced vendors to execute periodic aggregate reports (e.g., PADERs, PBRERs).
• Ensure compliance with regulatory requirements for all aggregate safety deliverables; monitor and ensure vendor adherence to Tolmar and partner standards.
• Manage safety reporting schedules and maintain compliance metrics.
• Support updates to Company labeling, including CCDS, Canadian Monograph, and US Full Prescribing Information.
• Provide or coordinate medically sound responses to regulatory inquiries related to assigned products, including ICSR‑related questions.
• Support development, maintenance, and compliance monitoring of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) with Market Authorization Holders.
• Represent Tolmar in internal and vendor meetings.
• Identify, escalate, and recommend mitigation strategies for safety or compliance issues.
• Support medical review activities and collaborate with Tolmar’s and/or partners’ Quality Departments for adverse events associated with product complaints.
• Coordinate product quality investigations when adverse events indicate the need for evaluation.
• Support readiness for internal and external audits/inspections, ensuring compliance with FDA and Health Canada requirements, especially regarding aggregate reporting processes.
• Assume managerial oversight of PVPS team member as assigned.  
• Perform additional responsibilities as assigned.

Knowledge, Skills & Abilities 

• Strong ability to collaborate effectively across multidisciplinary teams (Clinical Development, Regulatory, Quality Assurance, Legal) and with external partners.
• Demonstrated expertise in pharmacovigilance operations and vendor management.
• Excellent verbal and written communication skills.
• Strong conflict‑resolution and problem‑solving abilities.
• Ability to work autonomously and within cross‑functional teams.
• Proven ability to manage multiple priorities, meet deadlines, and operate effectively in a fast‑paced environment.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project, Outlook).
• Ability to perform effectively under pressure.
• Excellent team management skills.

 Core Values

This position is expected to operate within the framework of Tolmar’s Core Values:

• Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​
• Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​
• Act Ethically:We are committed to consistently conducting our business in an ethical, compliant,