DSMI Training and Development Specialist

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 and act as a subject matter expert with respect to Pharmacovigilance training and compliance. This role will further involve delivering training on Pharmacovigilance (PV) procedures in line with Patient Support Program (PSP) Pharmacovigilance Agreement (PVA). DUTIES AND RESPONSIBILITIES • 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, and training matrix (as required). • 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 colleagues 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 support 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 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. • 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. Job Qualification QUALIFICATIONS ➢ EDUCATION • Professional degree and/or advanced background in Health Sciences disciplines and/or Quality & Training Certification and/or equivalent combination of education and experience. ➢ EXPERIENCE • Minimum Three (3) years of previous experience driving and implementing training and quality 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 proven attention to detail. • Ability to work with strict timelines and handle multiple priorities. • Flexible, adaptable and able to work under pressure and convey a sense of urgency. • Demonstrated initiative and accountability. • Excellent customer service skills to deal with client questions, sometimes under difficult circumstances. • Team Player with ability to function in a multi-disciplinary environment and promote collaboration. • Proficiency with standard desktop computing programs (Microsoft Office – Word, Excel, PowerPoint, Visio etc.) and relational databases. • Experience with communication software and tools (e.g., SharePoint, online learning platforms, etc.). • Ability to communicate and comprehend in French is strongly desired. OTHER SKILLS AND ABILITIES • Maintain 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. • Ensure education and quality assurance programs adhere to government, company and ISO 9001-2000 standards. • Maintain confidentiality of patient, client and corporate information at all times