Local Qualified Person for Pharmacovigilance / Pharmacovigilance Officer - Malaysia
Primary Location: Petaling Jaya, Selangor, Malaysia Full time R1350350 投稿日: 02/02/2023
IQVIA Malaysia is looking to hire a Local Qualified Person for Pharmacovigilance. You will act as the Responsible Person for PV (RPPV) for customers requiring the services for their product. You will develop and prepare pharmacovigilance agreements for assigned customers, prepare pharmacovigilance systems master files under direct supervision.
- Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
- Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.
- Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal l products.
- Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.
- Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
- Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
- Deal directly with the Competent Authority and undergo questioning by regulatory authority inspectors during statutory inspections.
- Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.
- Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.
- Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.
- Around 4 years relevant clinical experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.
- Resident in Malaysia with fluent Bahasa Malaysia skills & excellent command of the English language
- In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
- Excellent knowledge of the pharmacovigilance legal framework in the EU and in Malaysia.
- Solid knowledge of relevant Standard Operating Procedures (SOPs).
- Possess excellent written and verbal communication skills.
- Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections.
- Strong organizational and project management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, customers and third parties
- Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
- Demonstrate an understanding of compliance and of quality management systems
- Availability by phone 24/7 for Competent Authority enquiries
- May require some travel
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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