Marie Raphaelle Moazazi
Patient Safety Scientist
Montreal,Canada
Summary
Global leader in patient safety and risk management with proven expertise in pharmacovigilance, safety strategy, and regulatory affairs. Skilled in global safety governance, signal management, and Risk Management Plan (RMP) development. Achievements include enhancing PV Quality Management Systems and ensuring compliance with international regulations. Experienced in building high-performing teams and leading complex safety initiatives to improve patient safety outcomes. Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Hardworking employee with customer service, multitasking, and time management abilities. Devoted to giving every customer a positive and memorable experience.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Associate Director, Patient Safety Scientist
Bristol Myers Squibb
04.2025 - Current
- Supported Global Patient Safety and Global Safety Leaders with safety assessments, benefit-risk strategies, and cross-functional collaboration
- Directed the development, implementation, and monitoring of RMPs and additional risk minimization measures (ARMMs) while guiding Local Markets including META regions on compliant risk minimization strategy execution
- Led and participated in the review of aggregate safety reports (DSUR, PSUR, SARs)
- Led the ARMM Effectiveness Evaluation Methodology workstream, developing RACI matrices, templates and SOP
- Identified and communicated emerging safety concerns, ensured prompt updates to Company Core Data Sheet, Investigator’s Brochure, and local product labeling
- Maintained regular, effective liaison with Global TA Group Lead and QPPV
- Reviewed and provided safety input for key study documents and participated in protocol development
- Global position based in Canada
Associate Director, Global Risk Management Strategy
Bristol Myers Squibb
11.2022 - 03.2025
- Led end-to-end development, implementation, and tracking of RMPs and ARMMs
- Provided risk-management guidance in accordance with legislation for the development, implementation, and execution of risk-minimization strategies in local markets, including META countries
- Provided subject matter expertise for inspection readiness, audits, and Health Authority inspections
- Supported Local Markets in addressing RMP-related Health Authority queries and contributed to Rapid Response Team activities
- Assisted in aggregate safety report (DSUR, PBRER/PSUR) preparation and procedural documents updates
- Global position-based in Canada
Senior Manager, Global Risk Management Strategy
Bristol Myers Squibb
11.2020 - 10.2022
- Led end-to-end RMP and development, implementation, and governance for Immunology and cardiovascular products
- Implemented process improvements based on inspection readiness results and stakeholder feedback
- Managed PSMF updates and vendor agreements in alignment with global PV requirements
- Collaborated with cross-functional teams to strengthen the PV Quality Management System (QMS), driving consistency, operational excellence, and audit/inspection preparedness
- Global position based in Canada
Senior Pharmacovigilance Associate (Back up for the PV Head of Country)
Bristol Myers Squibb
02.2016 - 10.2020
- Evaluated and submitted individual case safety reports (ICSRs)
- Co-led digitization and decommissioning projects for Oncology ARMMs
- Trained staff and Patient Support Programs (PSP) with safety reporting obligations
- Maintained process compliance and QC metrics
- Led process assessment and oversight for Foreign Safety Notification related to important and urgent safety concerns, with endorsement by QPPV
- Collaborated with cross-functional teams to develop CAPAs for inspection findings
- Co-led the development, maintenance, and effectiveness evaluation of local PV controlled documents for the business unit
- Canada
Pharmacovigilance Specialist
Sanofi
01.2014 - 02.2016
- Supported PV techno vigilance (TV) activities for medical devices, and ensured compliance with PV Techno vigilance and safety reporting requirements
- Managed end-to-end case processing for adverse events, product complaints, and device incidents evaluation and follow-up with manufacturer
- Collaborated with patient programs to ensure proper AE/PC collection, and alignment with safety reporting obligations
- Conducted safety data reconciliation between PSP databases, medical information, and PV systems to ensure data integrity
- Canada
Head, Regulatory Affairs & Responsible Pharmacist
Novo Nordisk
11.2011 - 05.2013
- Directed all Regulatory Affairs and Pharmacovigilance for the affiliate, including timely preparation and submission of dossiers for new products and variations
- Prepared and maintained labeling and responses to regulatory queries
- Led inspection readiness, audit planning, and direct communication with Ministry of Health and META Lead
- Oversaw regulatory and Pharmacovigilance strategies, ensuring compliance with global and local requirements, and coordinated reporting deadlines
- Supervised team for training on regulatory and PV procedures, SOP updates, and documentation standards
- Led, mentored, and motivated a multi-functional regulatory team, fostering a collaborative environment, enhancing performance, and ensuring alignment with organizational goals
- Iran
Regulatory Affairs Director
Cobel Darou - Agent of Sanofi, and MSD vaccines
10.2005 - 04.2011
- Led all regulatory submissions (new registrations, variations) and label updates for Sanofi medicines and MSD vaccines
- Managed team responsible for regulatory documentation, ensured compliance with local/global SOPs and standards
- Coordinated audit/inspection readiness, crafted CAPA plans, and ensured successful regulatory approvals
- Administered product labeling, maintained regulatory intelligence, and implemented new regulatory processes in line with evolving HA requirements
- Led, trained, and inspired the regulatory affairs team, delegated responsibilities effectively, and promoted ongoing professional growth and teamwork
- Iran
Education
MBA -
HEC Montreal
Diploma in Fundamental Virology -
Pierre & Marie Curie University
Pharmacist Doctor -
Tehran University of Medical Sciences
Skills
- Global Safety Governance & Risk Management
- Signal Detection & Benefit–Risk Evaluation
- RMP/ARMM Strategy & Implementation
- Aggregate Safety Reporting (PSUR/PBRER/DSUR)
- PV Quality Management System (QMS) Leadership
- Inspection Readiness & Compliance (FDA, EMA, GVP, META)
- Cross-Functional & Senior Stakeholder Collaboration
- SOP Governance, Process Optimization & Change Leadership
- Team Leadership, Coaching & Capability Building
Certification
- FPGEC
- NAPLEX
- MPJE
Languages
- English, Fluent
- French, Mother tongue
- Farsi, Mother tongue
- Arabic, Elementary
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Languages
French
Native language
English
Proficient (C2)
C2
Additional Information
I am a Flexible person and ready to relocate
Timeline
Associate Director, Patient Safety Scientist
Bristol Myers Squibb
04.2025 - Current
Associate Director, Global Risk Management Strategy
Bristol Myers Squibb
11.2022 - 03.2025
Senior Manager, Global Risk Management Strategy
Bristol Myers Squibb
11.2020 - 10.2022
Senior Pharmacovigilance Associate (Back up for the PV Head of Country)
Bristol Myers Squibb
02.2016 - 10.2020
Pharmacovigilance Specialist
Sanofi
01.2014 - 02.2016
Head, Regulatory Affairs & Responsible Pharmacist
Novo Nordisk
11.2011 - 05.2013
Regulatory Affairs Director
Cobel Darou - Agent of Sanofi, and MSD vaccines
10.2005 - 04.2011
MBA -
HEC Montreal
Diploma in Fundamental Virology -
Pierre & Marie Curie University
Pharmacist Doctor -
Tehran University of Medical Sciences