DSMI Training and Development Specialist

Bayshore HealthCare; Ontario; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading healthcare company is seeking an Implementation & Training Specialist to develop and implement Pharmacovigilance processes for their Patient Support Program. The role involves training staff, ensuring compliance with health guidelines, and improving quality initiatives. Candidates should have a strong background in Health Sciences and experience in training and quality management.

Qualifications

• Minimum of 3 years in training and quality initiatives.
• Experience in course design, pharma audits, and investigations preferred.

Responsibilities

• Develop and implement Pharmacovigilance standard policies and procedures.
• Create training materials for patient support programs.
• Conduct internal audits and establish CAPAs.

Skills

Communication

Organizational Skills

Critical Thinking

Coaching

French

Education

Professional degree in Health Sciences

Quality & Training Certification

Tools

Microsoft Office

Job description

The Implementation & Training Specialist will lead the development, review, approval, maintenance, and implementation of Pharmacovigilance processes and procedures in time for Patient Support Program launch. They will act as a subject matter expert in Pharmacovigilance training and compliance. The role involves delivering training on Pharmacovigilance (PV) procedures aligned with the Patient Support Program (PSP) Pharmacovigilance Agreement (PVA).

DUTIES AND RESPONSIBILITIES

1. Develop and implement Pharmacovigilance standard policies and procedures to meet PSP PVA requirements.
2. Create and execute training and educational materials for successful launch or transition of patient support programs related to Pharmacovigilance and Medical Information services.
3. Review existing PV and MI procedures, identify opportunities for improvement, and standardize practices in line with industry trends and best practices.
4. Communicate regularly with the Implementation team regarding PSP launch/transition updates and track upcoming activities.
5. Develop and maintain a training matrix for the Scientific Affairs (SCA) team.
6. On-board new employees, ensuring their training complies with the training matrix.
7. Maintain annual updates of Bayshore PV training, policies, and training matrix, ensuring compliance with Health Canada guidelines and good pharmacovigilance practices.
8. Provide PV training and MAH-specific PV training to SCA colleagues and key stakeholders via virtual and e-learning methods to ensure contractual and program requirements are met.
9. Coordinate and deliver training sessions on Product Training, AE / PC reporting, MI inquiry handling, and Quality topics for new and existing staff.
10. Ensure staff training is current and refreshed per schedule and contractual obligations.
11. Support program staff and DSMI staff with ongoing pharmacovigilance expertise on safety event detection, assessment, and reporting.
12. Assist in audit preparations, including training records and documentation.
13. Conduct internal audits, root cause analyses, and establish CAPAs to ensure ongoing compliance.
14. Perform risk assessments, trend analysis, and recommend quality improvements.
15. Maintain and review professional records for the SCA team annually.
16. Perform other duties as assigned.

QUALIFICATIONS

EDUCATION

• Professional degree or advanced background in Health Sciences, Quality & Training Certification, or equivalent experience.

EXPERIENCE

• Minimum of 3 years in training and quality initiatives, with experience in course design, pharma audits, and investigations preferred.

Skills

• Ability to coach, mentor, and train; excellent communication; organizational and critical thinking skills; ability to handle multiple priorities under pressure; proficiency in Microsoft Office and communication tools; French language skills are highly desired.

OTHER SKILLS AND ABILITIES

• Knowledge of ICH, GDP, GCP, GMP, ISO, and ASQ guidelines; understanding of Six Sigma; ability to maintain confidentiality.