Qualified Person Responsible for Pharmacovigilance (QPPV)

About the Role

Klybeck Life Sciences is seeking a Qualified Person Responsible for Pharmacovigilance (QPPV) to join our team in Dammam, Eastern Region. This full-time role involves overseeing pharmacovigilance activities and supporting regulatory affairs for pharmaceutical products.

Role Overview

The QPPV will ensure compliance with Saudi Food and Drug Authority (SFDA) requirements for pharmacovigilance. The position requires coordination with regulatory bodies and internal teams to manage product safety and registration processes effectively.

Key Responsibilities

• Serve as the Qualified Person Responsible for Pharmacovigilance (QPPV) for pharmaceutical products, ensuring adherence to applicable SFDA requirements.
• Coordinate product registration and follow up on regulatory matters with the Saudi Food and Drug Authority (SFDA).
• Oversee pharmacovigilance activities, including adverse event reporting, safety case processing, and maintaining relevant safety documentation.
• Collaborate with the Regulatory Affairs team to ensure compliance with applicable regulatory requirements and timely completion of submissions and follow-up activities.

Qualifications and Requirements

• Bachelor’s degree in Pharmacy.
• 3–4 years of relevant experience in Pharmacovigilance.
• Registration with the Saudi Commission for Health Specialties (SCFHS).
• Knowledge of pharmacovigilance principles and applicable SFDA regulations.
• Familiarity with adverse event reporting and regulatory documentation.

Experience Level

Candidates should possess 2-5 years of professional experience, specifically within the field of Pharmacovigilance.

Application Process

Klybeck Life Sciences invites qualified professionals to apply for this position. Salary details will be discussed during the interview process.