Associate Manager, Drug Safety Compliance
2 weeks ago
The **Associate Manager, Drug Safety Compliance **will act as a Pharmacovigilance (PV) Compliance expert for PV Operations across the assigned Patient Support Program(s). This role will partner with Drug Safety & Medical Information (DSMI) team and Cross Functional Specialty teams to enhance compliance with our PV contractual obligations, PV key performance indicators and GVP regulations.
DUTIES AND RESPONSIBILITIES
- Provide oversight of daily PV operations across the assigned patient support program(s) (PSP).
- Handles program PV escalations and provides guidance & support to the team as needed.
- Operationalizes and implements executed PVAs within the PSP.
- Proactively monitors and tracks PV KPIs for PV quality performance monitoring.
- Evaluates compliance with executed PVAs and PV KPIs on an on-going basis.
- Co-leads technological advancements and automation to enhance PV operational efficiency.
- Always ensures GVP audit readiness and contributes to internal and external PV Audit readiness.
- Oversees development, review, approval and maintenance of PV Work Instructions across assigned patent support programs.
- Co-leads the implementation of robust training matrix and training program within the department and monitors compliance with training requirements, including but not limited to QMS suite and any other program PV & product trainings.
- Drives the implementation of standard practices for maintaining professional records (resumes, job descriptions and organizational charts) for the assigned team.
- Identifies potential PV compliance risks and mitigates risks if any.
- Advises internal stakeholders of PV compliance risks, educates them and collectively mitigates PV compliance risks.
- Acts as a catalyst for process improvements to promote standardization and best PV practices.- Leads the education and implementation of robust Root Cause Analysis (RCA), achievable Corrective Actions and Preventive Actions (CAPA), and CAPA Effectiveness Checks for PV quality events and deviations.
- Monitor Health Canada GVP regulatory requirements and proactively adapt the internal processes to meet the changing regulations.
- Perform other PV compliance related duties as assigned, including but not limited to the following as/when needed:
- Preparation and submission of reconciliation reports as per the program PVA.
- Oversees and supports activities related to source data verification as per the program PVA.
- Assist in development and oversee implementation of required PV training and education for the PV team, 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 PV and program personnel and assist in annual retraining as mandated and required to meet the program PV obligations.
- Provide QE and CAPA training to PV team, program team and other cross-functional teams as needed.
- Provides input in RMP - Risk Management Plans and Special Access Programs.
- Drives the agenda and leads PV meetings with pharmaceutical client (s), proactively discuss any identified trends, and provide solutions for continuous process improvements.
- Assists with new PV proposals and business development initiatives while striving for operating efficiency & cost efficiency.
- Supports monthly PV billing activities.
- Effectively manages the team, ensures their growth & development, and provides performance feedback.
- Must be able to productively interact with all levels of internal and external stakeholders.
- Ensures compliance with Innovative Medicines Canada (IMC) code of ethical practices for Patient Support Programs (PSPs).
- Builds excellent rapport with both internal and external stakeholders.
**REPORTING RELATIONSHIPS**:
This role reports to the Scientific Affairs management team.
Job Qualification
Ø EDUCATION
Possess a degree in health sciences or life sciences or a scientific degree at a minimum, professional advanced scientific degree preferred or equivalent combination of education and experience will be considered.
Ø EXPERIENCE
- 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
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