Website Queens University
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, for pharmacovigilance, ensuring compliance with applicable regulations and guidelines, overseeing safety reporting, developing and implementing of policies and procedures, overseeing partner interactions, and contributing to the education and training of CCTG staff and trial participants.
- Creation of clear Standard Operating Procedures.
- Integration with information technology to ensure effective implementation of the unblinding SOP across Safety Desk and IT aspects.
- 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.
- Maintain knowledge of, and updates CCTG leadership teams and policies and processes, all applicable regulatory guidance nationally and internationally regarding safety including changes.
- When a new drug is added to CCTG portfolio, with the responsible Senior Investigator, creates the CCTG Master List of Expected Events (MEE) for each agent.
- Ensure CCTG has all amendments to Product Monographs and Investigator Brochures and, together with the responsible Senior Investigator, provide recommendations regarding Protocol and Informed Consent Updates, and ensure timely implementation.
- Ensure appropriate interaction with Health Authorities with regards to pharmacovigilance activities.
- With the responsible Senior Investigator, 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 (e.g. Electronic Data Capture Medidata Rave, CTEP systems for reporting, CCTG systems for reporting and distribution). Maintain knowledge of systems in place.
- Minimum of 5 years relevant experience in one or more of the following areas: clinical research, clinical trial methodology, pharmacovigilance, and/or quality assurance in a health-care setting.
- Experience in pharmacovigilance (safety reporting and monitoring) including hands-on experience with clinical trials.
- Leadership, mentoring, supervisory skills and ability to create a positive working environment for the team.
- Ability to work collaboratively within a team and across functional groups and portfolios, as well as the ability to work independently.
- Respects diversity and promotes inclusion in the workplace.
- Excellent communication skills both written and verbal; must have influencing and negotiating skills.
- 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.
- Knowledge, strong understanding and experience of regulations and their implementations (in particular ICH/GCP, HC, FDA, CTEP, OHRP) pertaining to clinical trials in Canada are required.
- Consideration may be given to an equivalent combination of education and experience.
Company: Queens University
Vacancy Type: Full Time
Job Location: Mississauga, CA
Application Deadline: N/A