Title: Specialist-Deputy QPPV & Quality
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Main Responsibility:
- The Qualified Person Responsible for Pharmacovigilance (QPPV) plays a pivotal role in ensuring compliance with regulatory requirements and overseeing the pharmacovigilance system within the Kingdom of Saudi Arabia (KSA).
- Their main responsibility involves establishing and maintaining the pharmacovigilance system, including creating local standard operating procedures (SOPs), handling adverse event reports, and ensuring compliance with SFDA regulations.
- Additionally, the QPPV is responsible for coordinating with regulatory authorities, conducting risk assessments, and contributing to regulatory actions in response to emerging safety concerns.
- They serve as the primary contact point for pharmacovigilance activities and must have authority over the pharmacovigilance system's functioning and quality assurance aspects.
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Qualifications:
- To be considered for the role of QPPV, candidates must meet the following qualifications:
- Bachelor's degree in Pharmacy or Medicine.
- Basic training in pharmacovigilance science.
- Licensing by the Saudi Commission for Health Specialties.
- In-depth knowledge of KSA pharmacovigilance requirements and regulations.
- Demonstrated experience in pharmacovigilance, preferably in a regulatory or pharmaceutical industry setting.
- Strong analytical and critical thinking skills.
- Excellent communication and stakeholder management abilities.
- Ability to work effectively in a regulatory environment and ensure compliance with legal requirements.
- Proven track record of leadership and decision-making in pharmacovigilance activities.
- Commitment to continuous learning and staying updated on pharmacovigilance best practices and guidelines.
- Additionally, candidates designated as Deputy QPPV should have the same qualifications as the QPPV, with a minimum of a bachelor's degree in Pharmacy or Medicine, basic training in pharmacovigilance science, and licensing by the Saudi Commission for Health Specialties. They should also receive training on the pharmacovigilance system before assuming the role and have adequate theoretical and practical knowledge to perform pharmacovigilance activities effectively.