Pharmacovigilance Specialist

Role Overview

As a Pharmacovigilance Specialist within Sanofi’s Patient Safety & Pharmacovigilance (PSPV) team in Riyadh, Saudi Arabia, you will play a pivotal role in ensuring the safe and appropriate use of Sanofi’s products across the local market. Your responsibilities will encompass the full spectrum of pharmacovigilance activities, including compliance with global and regional regulations, risk management, and timely safety reporting. This position is ideal for professionals who are passionate about patient safety and committed to upholding the highest standards of pharmacovigilance excellence.

Key Responsibilities

In this critical role, you will be responsible for the following core functions:

• Regulatory Compliance: Ensure all local pharmacovigilance activities adhere to Sanofi’s global PV policies, as well as regional and local regulatory requirements, to guarantee the safe use of Sanofi products in Saudi Arabia.
• System Maintenance & Improvement: Support the establishment, maintenance, and continuous enhancement of the local Pharmacovigilance System, ensuring it remains robust, efficient, and fully prepared for inspections and audits.
• Safety Data Management: Monitor incoming communications to promptly identify and manage Individual Case Safety Reports (ICSRs) and other safety-related information, escalating critical data to Global PSPV entities, Health Authorities, and external partners as required.
• Local PV Support: Provide pharmacovigilance oversight for Patient Support Programs, Market Research, Managed Access Programs, and company-sponsored digital media initiatives, ensuring all activities comply with PV requirements.
• Reporting & Documentation: Prepare and submit periodic safety reports, including Periodic Safety Reports (PSRs) and periodic reviews, in accordance with regulatory timelines.
• Emergency Response: Adhere to the local business continuity plan and after-hours emergency call protocols, ensuring immediate escalation of safety alerts and adherence to established procedures.
• Collaboration & Escalation: Work closely with Global Safety Officers (GSOs) to support local safety surveillance activities, including the timely handling and escalation of product safety alerts.
• Risk Management: Contribute to risk management initiatives and additional risk minimization measures in Saudi Arabia, coordinating with internal and external stakeholders to mitigate potential safety concerns.
• Training & Compliance: Complete assigned PV Liaison role trainings promptly and maintain compliance with Sanofi’s internal Code of Ethics and Health, Safety, and Environment (HSE) standards.

Qualifications & Skills

To excel in this role, you should possess the following qualifications and attributes:

• A Bachelor’s degree in Pharmacy or a related field.
• Minimum of 3 years of professional experience in Pharmacovigilance, drug safety, or a closely related regulatory/medical discipline.
• In-depth knowledge of local pharmacovigilance regulations, safety reporting requirements, and risk management frameworks.
• Proven ability to collaborate effectively with cross-functional teams, including Quality, Regulatory, and Medical Affairs.
• Exceptional attention to detail and the capacity to manage time-sensitive safety reporting obligations with precision.
• Strong written and verbal communication skills, enabling clear and effective coordination with Health Authorities, service providers, and internal stakeholders.
• Fluency in English is mandatory; proficiency in Arabic is highly advantageous.
• Self-motivated with a strong ethical mindset and an unwavering commitment to patient safety.

Why Join Sanofi?

Choosing to join Sanofi means becoming part of a global biopharmaceutical leader dedicated to transforming lives through innovative science and patient-centric solutions. As a Pharmacovigilance Specialist, you will:

• Make a Meaningful Impact: Contribute to the development and delivery of life-changing treatments that benefit millions of patients worldwide.
• Champion Patient Safety: Play a vital role in safeguarding patient well-being by ensuring every Sanofi product meets the highest standards of pharmacovigilance compliance.
• Drive Innovation & Collaboration: Work alongside diverse teams across science, medicine, and operations to build efficient systems and foster innovation that accelerates progress.
• Advance Your Career: Benefit from structured development opportunities, including stretch roles, cross-functional mobility, and tailored training programs designed to align with your professional aspirations.
• Thrive in a Supportive Environment: Be part of a high-performing, inclusive culture that values collaboration, integrity, and excellence.

If you are a detail-oriented professional with a passion for pharmacovigilance and a commitment to patient safety, we invite you to apply and take the next step in your career with Sanofi.