Pharmacovigilance Team Leader

Competition Number: J0425-0337

Position Title: Pharmacovigilance Team Leader

Position Number (Final): 00503046

Employee Group: Research, Grant & Contract

Job Category: Research

Department or Area: Canadian Cancer Trials Group

Location: Kingston, Ontario, Canada (Hybrid)

Grade: 09 Review Salary Information Here

Hours per Week: 35

Job Type: Term

Length of term: 18

Shift: 7 Monday - Friday

Number Of Positions: 1

Date Posted: April 15, 2025

Closing Date: April 29, 2025

Queen’s University is the Canadian research intensive university with a transformative student learning experience. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.

We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.

Reporting to the Manager Office of Compliance and Oversight, the incumbent will oversee pharmacovigilance activities at the Canadian Cancer Trials Group (CCTG). The core responsibilities of the Pharmacovigilance Team Leader include ensuring compliance with applicable regulations and guidelines, overseeing safety reporting, developing and implementing policies and procedures, overseeing partner interactions, and contributing to the education and training of CCTG staff and trial participants.

• Develop and implement Pharmacovigilance Standard Operating Procedures (SOP’s) and Work Instructions (WKI’s) to ensure quality and consistency with CCTG policies and procedures.
• Oversee and assess the training and education of CCTG staff and the external network.
• Develop training materials and evaluations and ensure all documentation of team methods and policies is up to date and consistent with current regulations and guidelines.
• Oversee all CCTG pharmacovigilance activities to ensure compliance with regulations and guidelines.
• Lead discussions with partners regarding appropriate safety reporting plans for multi-national and international trials.
• Ensure trial contracts address safety reporting requirements to ensure compliance.
• Develop safety reporting plans for trials and risk sections for Informed Consent Forms.
• Ensure quality systems are in place to support pharmacovigilance.
• Maintain knowledge of applicable regulatory guidance nationally and internationally regarding safety.
• Manage the safety oversight processes of the group to ensure effective and compliant implementation of agreed safety reporting plans.
• Manage unblinding procedures, where applicable.
• Lead the Safety Desk team regarding processing, tracking, reporting and monitoring safety information.
• Provide work direction, and technical/functional guidance to Safety Desk team staff.
• Participate in screening and interviewing job candidates.
• Develop and implement a quality plan for pharmacovigilance processes and report to the Manager, OCO.
• Undertakes additional duties as assigned, in support of the Safety Desk and the CCTG unit.

• Master’s degree or PhD in Health Sciences, Pharmaceutical Sciences or equivalent program of study; health care/medical background required.
• Demonstrated advanced understanding of drug development, drug safety requirements and adverse event reporting.
• Minimum of 5 years relevant experience in clinical research, clinical trial methodology, pharmacovigilance, and/or quality assurance in a health-care setting.
• Experience in pharmacovigilance including hands-on experience with clinical trials.
• Knowledge and experience of regulations pertaining to clinical trials in Canada.

• Respects diversity and promotes inclusion in the workplace.
• Excellent communication skills both written and verbal.
• Leadership, mentoring, supervisory skills.
• Ability to work collaboratively within a team and across functional groups.
• Strong analytical, detail oriented, and organized approach to work.
• Effective project management skills.
• Exceptional computer skills.

• Write and review standard operating procedures and work instructions.
• Oversee implementation of SOPs/WKIS.
• Identify improvement opportunities and address inconsistencies.
• Provide training and support.
• Assess and interpret standards and guidelines pertaining to pharmacovigilance.
• Regular handling of sensitive and confidential information.

Employment Equity and Accessibility Statement: The University invites applications from all qualified individuals. Queen’s is committed to employment equity and diversity in the workplace and welcomes applications from women, visible minorities, Aboriginal Peoples, persons with disabilities, and persons of any sexual orientation or gender identity.