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Pharmacovigilance Team Leader

Queen's Student Alumni Association • Kingston, Ontario, Canada • 7h ago

About Queen's University

Job Summary

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.
Participate in screening and interviewing job candidates, and providing input into staff selection.
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 (safety reporting and monitoring) including hands-on experience with clinical trials.
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.

Special Skills

Respects diversity and promotes inclusion in the workplace.
Excellent communication skills both written and verbal; must have influencing and negotiating skills.
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.
Knowledge of policies, standards and procedures involved in reporting safety information for clinical trials.
Interpersonal and communication skills (both verbal and written) to deal with a wide variety of individuals in a professional manner and to provide clear and accurate information.
Ability to multi-task in a changing environment with the ability to prioritize workload and meet deadlines.
Ability to problem solve and exercise discretion. Must have the ability to adhere to strict confidentiality, ability to recognize and handle confidential information in an appropriate manner.
Strong analytical, detail orientated, and organized approach to work.
Ability to think critically and accurately review and interpret medical information.
Ability to make formal presentations at CCTG, nationally, and internationally.
Effective project management skills to plan, implement, and evaluate projects and initiatives.
Exceptional computer skills, for example Oracle, email, Word, Excel, PowerPoint, Electronic Data Capture (Medidata RAVE).

Decision Making

Write and review standard operating procedures and work instructions with a focus on pharmacovigilance. Ensure appropriate processes are in followed including obtaining the required approvals.
Oversee implementation of SOPs/WKIS with a focus on data management and quality assurance.
Identify improvement opportunities and address inconsistencies with team practices.
Provide training and support to ensure consistency across pharmacovigilance activities.
Ensure effective communication across the Safety Desk team and provides oversight from an HR perspective with respect to delegation and workload management.
Assess and interpret standards and guidelines pertaining to pharmacovigilance.
Provide recommendations to the group regarding compliance requirements and changes in the regulatory environment to ensure safety.
Identify risks related to patients, the clinical trials conducted, and the CCTG from a pharmacovigilance perspective.
Interface effectively within the OCO and across CCTG portfolios, as well as the leadership team to manage compliance with regulations and guidelines.
Regular handling of sensitive and confidential information for which discretion is required.
Provide recommendations on best alternatives to a given problem, identifying potential risks and benefits of each.
Assess the suitability of job candidates and recommend the most appropriate person for hire.
Determine priorities and make decisions about staff utilization and the assignment of work to achieve optimum efficiencies and productivity.
Assess employees' training needs and make recommendations for internal or external training to attain proficiency.
Monitor and assess output and the quality of employees' work, and recommend need for formal training or development plans to management and identify possible staff performance and/or disciplinary issues.