Local Qualified Person For Pharmacovigilance

4+ years

Not Disclosed

Riyadh

10 Sept. 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Local Qualified Person (QP) for Pharmacovigilance

Location: Saudi Arabia (Home-Based / Hybrid / Office-Based)

As a Local Qualified Person (QP) for Pharmacovigilance, you will serve as the local QP for clients requiring support for their products.

Responsibilities:

Act as the local Qualified Person in accordance with the requirements outlined in the IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
Be available 24/7 to respond to calls from the local Competent Authority and serve as the contact point during pharmacovigilance inspections.
Address requests from Competent Authorities regarding the evaluation of benefits and risks of medicinal products, including information related to sales, prescriptions, or post-authorization safety studies.
Ensure that your name and contact details are registered with the Competent Authority upon contract commencement.
Stay informed about local regulatory changes and verify that necessary safety measures and risk management plans are implemented.
Maintain a comprehensive understanding of each project’s budget and scope of work (SOW), and manage project materials such as files, forms, templates, databases, and workflows.
Provide regular reports to the project manager regarding project metrics, changes to SOW, and customer inquiries or concerns.
Deliver monthly updates to the EU QPPV/designee and complete regulatory reports as necessary.

Minimum Required Education and Experience:

Bachelor’s degree in life sciences, medicine, pharmacy, nursing, or an equivalent educational background.
Approximately 4 years of relevant clinical experience, including managing clinical trial safety or post-marketing safety, or an equivalent combination of education, training, and experience.
Resident in Saudi Arabia with fluent Arabic skills (minimum C2 level).
Excellent command of the English language.

Required Knowledge, Skills, and Abilities:

In-depth knowledge of global, regional, and local regulatory requirements, including ICH guidelines.
Strong understanding of the pharmacovigilance legal framework in Saudi Arabia.
Familiarity with relevant Standard Operating Procedures (SOPs).
Excellent written and verbal communication skills.
Strong analytical and problem-solving abilities for interpreting safety reports and literature.
Solid organizational and project management skills.
Ability to establish and maintain effective relationships with colleagues, managers, customers, and third parties.
Maintain an overview of the safety profile of products and factors influencing the benefit/risk balance.
Understanding of compliance and quality management systems.

Physical Requirements:

Availability by phone 24/7 for inquiries from the Competent Authority.
Resident in Saudi Arabia.

About IQVIA:

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to enhance patient outcomes and improve population health worldwide.

To learn more, visit IQVIA Careers.

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