Implementation & Training Specialist, Drug Safety &

5 months ago

Mississauga, Canada Bayshore HealthCare Full time

**ABOUT THE ROLE**:
**PLEASE NOTE THIS IS A REMOTE POSITION.**

**A DAY IN THE LIFE**:

- Responsible for the development and implementation of Pharmacovigilance standard policies and procedures, in order to meet PSP PVA requirements.
- Responsible for the development and execution of required training and educational materials to enable successful launch (or transition) of patient support programs (as related to Pharmacovigilance and Medical Information services).
- Review existing PV and MI procedures and identify opportunities for improvement in an effort to standardize PV and MI practices, keeping in line with new trends and best industry practices.
- Regularly communicate with the Implementation team on PSP launch/transition updates and track upcoming launches/transitions.
- Develop and maintain a training matrix for the Scientific Affairs (SCA) team.
- On-board new department employees and ensure their trainings are compliant with the training matrix.
- Maintain Bayshore PV training and related policy annually.
- Ensure standard Bayshore PV training meets Health Canada’s post marketing adverse event reporting guidelines and good pharmacovigilance practices.
- Being the training SME and department trainer, provide Bayshore PV training and/or Market Authorization Holder (MAH) specific PV training to SCA department and as needed to key internal stakeholders through virtual and e-learning training methods to ensure compliance with overarching training policy, contractual agreement with MAH and program training requirements.
- Facilitate training assignments for the SCA team in line with PSP and PVA obligations.
- Coordinate and deliver training sessions with respect to: Product Training, AE/PC reporting, MI inquiry handling and Quality trainings (i.e. Good Documentation Practices, PV-Quality Check, and Document Change Control Management etc.) for new and existing department employees.
- Develop supplemental PV training resources (guides, cheat sheets, presentations, etc.) to ensure staff are compliant, keeping in line with new trends and best practices.
- Ensure training (PV, MI & Product training) of the department staff is up to date and refreshed as per agreed upon schedule with the MAH/contractual agreements.
- Provide ongoing support and pharmacovigilance expertise to program staff and DSMI staff members on the detection, assessment, prevention, understanding and reporting of all safety events (i.e. Initial AEs, Follow-up AEs and PQCs).
- Support internal and external audit preparation and related requests for training records and other documentation.
- Assist the Quality team in maintaining department audit related documents with respect to training on QMS SOPs and WIs.
- Assist the Quality team in conducting internal department audits, specifically to track training compliance with SOPs/WIs/Policies and contractual PV and/or MI obligations.
- Conduct root cause analysis (RCA), thorough investigation for non-conformances, and help establish robust Corrective and Preventive Actions (CAPAs) to ensure on-going compliance with documented processes and training.
- In collaboration with the Quality team, conduct training on effective and robust RCA and CAPA writing skills to the SCA team and internal stakeholders.
- Assist in conducting compliance risk assessments, trend analysis, and provide solutions and recommendations for improving quality and compliance.
- Maintain and store professional records (CVs and JDs) for the SCA team and ensure annual review of records are being completed.
- Perform other duties as assigned.
- Maintain current knowledge of:

- ICH (International Conference on Harmonization),
- GDP (Good Documentation Practices),
- GCP (Good Clinical Practice),
- GMP (Good Manufacturing Practices),
- Health Canada GVP (Good Pharmacovigilance Practices),
- Health Canada guidelines for Reporting Adverse Reactions to Marketed Health Products
- Global PV regulations,
- Pharmacovigilance post marketing compliance audits,
- Medical Information (MI) practices,
- ISO, and ASQ guidelines.
- Knowledge and understanding of Six Sigma concepts.
- Maintain confidentiality of client and corporate information at all times.

Job Qualification

**WHAT YOU BRING TO THE TEAM**:

- Professional degree in Health Sciences disciplines and/or Quality Compliance & Training Certification.
- Minimum Three (3) years of previous experience driving and implementing training and quality compliance initiatives.
- Demonstrated comprehension of course design and delivery of training.
- Experience in handling internal and external Pharma audits and/or board of health inspections.
- Experience in handling root cause analysis, investigations and CAPA generation preferred.
- Knowledge on current Pharmaceutical quality standards an asset.
- Ability to successfully coach, mentor, train and provide ongoing education.
- Excellent written, verbal, and facilitation skills.
- Excellent organizational & critical thinking skills and prov

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