Marketed Product Safety Specialist 2
5 months ago
**Responsibilities**:
- 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.
**Requirements**:
- 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 inquiries
- May require some travel
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