Implementation & Training Specialist, Drug Safety & - Mississauga, Canada - Bayshore HealthCare

Bayshore HealthCare

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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.
Onboard 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 elearning 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, Followup 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 nonconformances, and help establish robust Corrective and Preventive Actions (CAPAs) to ensure ongoing 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