Associate Director PSS, Canada Remote Based

Fortrea • Toronto, ON

4d • CA$140,000 - CA$180,000 • Remote

About The Position

We are seeking an accomplished Associate Director with patient safety solutions expertise who is seasoned in aggregate writing and leadership. The Associate Director – PSS will manage regional pharmacovigilance operations across Europe, Asia-Pacific, or the Americas. This role ensures the effective delivery of high‑quality, compliant safety services while maintaining operational efficiency, scalability, and client satisfaction across a dynamic portfolio of projects.

Requirements

• RN + 10 yrs. relevant experience
• BS/BA + 8 yrs. relevant experience
• MS/MA + 6 yrs. relevant experience
• PharmD + 4 yrs. relevant experience
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety.
• At least 6 years of experience specifically in safety/AE processing
• A minimum of 4 years’ supervisory experience (i.e., in project management or line management).
• Speaking: English and local language.
• Writing/Reading: English and local language.
• Candidates must be authorized to work in the United States; employer sponsorship is not available for this position.
• At least 4 years’ line management and/or project management experience.
• Industry experience of which 6+years are relevant to drug safety knowledge.
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
• Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Knowledge of ICH guidelines.
• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
• Relevant experience includes experience in the pharmaceutical, biotechnology or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety.

Nice To Haves

• Knowledge of Medical Device reporting is desirable.
• Knowledge of Periodic Safety Update Report (PSUR) desirable.

Responsibilities

• May manage from 1-5 direct reports and up to 50 indirect subordinates.
• Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
• Engage in skill assessment and active skill development of direct reports – implementing development plans to ensure talent development.
• Provide appropriate and relevant PSS input into project management, including risk analysis, control metrics and contingency planning.
• Liaise with medical, clinical, data management, regulatory and QA personnel regarding safety issues, as appropriate.
• Ensure efficient, effective, and economic operation of PSS including management of quality, regulatory compliance, and adherence to project budgets.
• Ensure timely and appropriate reporting of expeditable adverse events to clients, regulatory authorities, ethics committees and investigators, as required.
• Support Business Development (BD) activities including client presentations and accurate input for costings and proposals.
• And all other duties as needed or assigned.

Benefits

• All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager