Pharmacovigilance Team Leader

Pharmacovigilance Team Leader

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Job Summary
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.

**Job Description**:
**KEY RESPONSIBILITIES**:

- Develop and implement Pharmacovigilance Standard Operating Procedures (SOP’s) and Work Instructions (WKI’s) to ensure quality and consistency with CCTG policies and procedures, including:

- 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 including:

- 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.
- Maintain knowledge of, and updates CCTG leadership teams and policies and processes, all applicable regulatory guidance nationally and internationally regarding safety including changes.
- Manage the safety oversight processes of the group to ensure effective and compliant implementation of agreed safety reporting plans, including:

- 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.
- Manages unblinding procedures, where applicable, including:

- Creation of clear Standard Operating Procedures.
- Integration with information technology to ensure effective implementation of the unblinding SOP across Safety Desk and IT aspects.
- Lead the Safety Desk team regarding the following:

- Process, track, report and monitor safety information (Serious Adverse Events/Safety Updates/Investigator Brochures/Product Monographs, other safety-related information) to ensure compliance with internal/external standards and national/international regulations.
- Provide work direction, and technical/functional guidance to Safety Desk team staff. Schedule and assign work, and oversee its completion. Coordinate and monitor work flow.
- Schedule and approve, or recommend the approval of, employees’ hours of work, overtime and absences. Monitor and oversee employee attendance.
- Review assignments and provide feedback on work to employees. Provide input on work performance to management staff.
- Provide orientation and on-the-job training to employees in the unit. Provide coaching and feedback on work quality issues, providing related day-to-day supervision. Escalate unresolved performance and/or disciplinary matters to the Manager, OCO.
- 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.

**REQUIRED QUALIFICATIONS**:

- 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 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 (safe