Associate Director PSS, Canada Remote Based

• Associate Director, PSS – Remote based Canada
• 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.

• Key / Core 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.

Qualifications (Required)

• RN + 10 yrs. relevant experience
• BS/BA + 8 yrs. relevant experience
• MS/MA + 6 yrs. relevant experience
• Pharm D + 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.
• To be considered for this position, candidate must possess relevant experience as outlined above, plus at least 6 years of experience specifically in safety/AE processing) along with a minimum of 4 years’ supervisory experience (i. e., in project management or line management).

Language Skills Required

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

Physical Demands / Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Pay Range

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.

Application Deadline

Learn more about our EEO & Accommodations request here.

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