Drug Safety Compliance Team Lead

3 weeks ago

Mississauga, Canada Bayshore HealthCare Full time

Drug Safety Compliance Team Lead is responsible for managing and overseeing the timely collection, processing, quality check and reporting of Safety events, ensuring compliance with Pharmacovigilance agreement (PVA), PV KPI monitoring and tracking as well as handling client inquiries. The incumbent will represent the Scientific Affairs Department at Bayshore Specialty Rx both internally and externally, take the lead in supporting program specific PV audits, and ensure Good Pharmacovigilance Practices (GVP) audit readiness at all times.**JOB SPECIFIC DUTIES AND RESPONSIBILITIES**
- Provide Pharmacovigilance expertise to support the program and pharmacovigilance team on the detection, assessment, processing, and reporting of all safety events.
- Ensure timely submission of initial and follow-up safety event reports as per the program PV agreement.
- Ensure quality, validity and accuracy of safety event reports.
- Perform quality check (QC) of adverse events/product quality complaints and all other applicable source documents to ensure compliance with PV reporting requirements.
- Oversee the management of PV inbox and conduct follow-ups.
- Preparation and submission of reconciliation reports as per the program PV agreement.
- As required, manage activities related to source data verification.
- Assist in development and oversee implementation of required PV training and education for the patient support program team, applicable cross-functional teams and subcontractors.
- Take train the trainer approach and assist in delivering program specific PV training,

product training or reporting portal training to program personnel and assist in annual retraining as mandated and required to meet the program PV obligations.- Initiate/Review/Complete Non-conformance Quality Events (QEs) to ensure compliance with program requirements and documented processes.
- Provide QE and CAPA training to program team and cross-functional team as needed.
- Lead PV activities and implementation for new program launches.
- Create or update program specific work instructions and process workflows.
- Review existing PV processes and identify opportunities for improvement, ensuring compliance and audit readiness at all times.
- Monitor monthly PV KPIs and proactively highlights trends to internal stakeholders for prompt solutioning.
- Drive the agenda and lead PV meetings with pharmaceutical client (s), proactively discuss any identified trends, and provide solutions for continuous process improvements.
- Proactively identify potential risks or gaps and provide risk mitigation strategies.
- Provide input in RMP - Risk Management Plans
- Take the lead in PV audit preparation and audit do’s and don’ts training for the program team. Support program specific audits as needed.
- Assist with new PV proposals and business development initiatives while striving for operating efficiency & cost efficiency.
- As required, act as the back-up for Drug Safety Manager/Team Lead.
- People leader managing Drug Safety & PV staff.
- Ensure compliance with Innovative Medicines Canada (IMC) code of ethical practices for Patient Support Programs (PSPs).
- Build excellent rapport with both internal and external stakeholders.

**GENERAL DUTIES AND RESPONSIBILITIES**
- Maintains confidentiality of patient, client, and corporate information at all times.
- Participates in proactive Health and Safety activities while performing all duties.
- Is responsible to notify immediate Supervisor of any Health and Safety risks or concerns.
- Participates in processes relating to regulatory and/or contractual reporting requirements.
- Ensure compliance with all applicable program specific trainings.
- Adheres to Bayshore’s Policies and Procedures.
- Completes other tasks as requested.

Job Qualification

**TECHNICAL QUALIFICATIONS & EXPERIENCE**:

- Degree in a health or life sciences field or a scientific degree at a minimum, professional advanced scientific degree preferred or equivalent combination of education and experience.
- Minimum 5 years of overall PV experience or related healthcare working experience (in Medical Information, Drug Safety-Pharmacovigilance, Medical Affairs, Regulatory Affairs, Clinical Trials or Healthcare Services environment).
- Experience in handling GVP Audits, CAPA generation and completion.
- Knowledge of current pharma PV practices and PV quality standards an asset.
- Knowledge of IMC Code of Ethical Practices for PSPs.
- Bilingual (English/French) is an asset.
- Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Health Canada GVP (Good Pharmacovigilance Practices), Canada Vigilance-MedEffect Program, GDP (Good Documentation Practices), GCP (Good Clinical Practices), Global PV Regulations, ICH Guidelines and Pharmacovigilance Auditing.
- Strong knowledge of drug benefit/risk profile, various disease states, internal medicine, physiology, toxicology and pharmacology will be considered an as

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