Global Product Safety Scientist

Sobi AB

Job Overview

Location

Raleigh, NC, us

Job Type

Full-time

Full Job Description

📋 Description

• As a Global Product Safety Scientist (GPSS) at Sobi AB, you will be an integral part of our mission to ensure the safety and well-being of patients who rely on our innovative therapies. This role is pivotal in providing essential safety scientific expertise, working in close partnership with the Global Product Safety Science Lead (GPSSL) to shape and execute the overarching Safety Science strategy for a portfolio of Sobi products. You will be a key contributor to maintaining the highest ethical and safety quality standards, ensuring patient safety and unwavering compliance with Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and all applicable worldwide regulatory requirements.
• A core aspect of your role will involve active collaboration within the product-level multidisciplinary Benefit-Risk Team (BRT). Here, you will contribute to critical activities such as proactive signal detection, rigorous analysis and validation of potential safety signals, the development and implementation of effective risk management strategies, and the meticulous maintenance of safety labeling for our products. Your insights will be crucial in ensuring that our benefit-risk profiles are continuously monitored and optimized.
• You will provide vital clinical safety input to various study teams, potentially taking on the responsibility of serving as the Safety Lead at the study level. This involves offering expert guidance on safety aspects throughout the lifecycle of clinical trials, ensuring that safety considerations are integrated from the outset and maintained throughout the study duration.
• A significant responsibility will be supporting the creation and ongoing maintenance of both core and EU Risk Management Plans (RMPs). This requires a deep understanding of regulatory requirements and a proactive approach to identifying and mitigating potential risks associated with our medicinal products.
• You will take the lead in the preparation of essential periodic safety reports, including but not limited to, Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs). Furthermore, you will make substantial contributions to comprehensive benefit-risk assessments, synthesizing complex safety data into clear and actionable conclusions.
• A key function of the GPSS is to diligently monitor, review, and evaluate incoming safety information from various sources. This proactive surveillance is critical for the early identification and assessment of potential safety signals, allowing for timely intervention and appropriate action.
• You will play a crucial role in contributing to regulatory submissions, engaging in interactions with health authorities, and ensuring the accuracy and completeness of product safety information presented in diverse regulatory documents.
• Effective liaison with external service providers will be a necessary part of your role, ensuring strategic alignment and the timely and high-quality delivery of documents and activities owned by the Safety Science function.
• You will support the development of product-specific case management guidance and contribute to the formulation of responses to medical safety inquiries, ensuring that all communications are accurate, timely, and compliant.
• Participation in comprehensive literature reviews and contributing to the development and execution of worldwide literature review strategies will be essential to stay abreast of the latest scientific information and potential safety concerns.
• Finally, you will provide crucial support during audits and inspections related to product safety, demonstrating Sobi's commitment to rigorous safety standards and regulatory compliance.

🎯 Requirements

• Proven experience in pharmacovigilance, drug safety, or a related pharmaceutical/biotechnology field, with a strong understanding of global regulatory requirements (e.g., GVP, GCP).
• Demonstrated ability to contribute to the development and implementation of product safety strategies, including signal detection, risk management, and benefit-risk assessment.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex scientific and regulatory information to diverse audiences.
• Strong analytical and problem-solving skills, with meticulous attention to detail and a commitment to data accuracy.
• Ability to work independently and collaboratively within multidisciplinary teams in a global environment.

🏖️ Benefits

• Opportunity to work with innovative therapies and contribute to patient well-being on a global scale.
• Collaborative and supportive work environment within a dynamic pharmacovigilance team.
• Competitive salary and comprehensive benefits package.
• Professional development and growth opportunities within a growing pharmaceutical company.
• Be part of a company culture that values integrity, patient focus, and scientific excellence.

Skills & Technologies

GCP

Onsite

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Sobi AB

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About Sobi AB

Sobi is a leading integrated biopharmaceutical company dedicated to advancing the lives of people with rare diseases. The company focuses on developing and commercializing innovative treatments in areas such as hematology, immunology, and specialty care. Sobi's business model centers on identifying unmet medical needs, investing in research and development, and bringing novel therapies to patients globally. They collaborate with partners to expand their pipeline and reach, aiming to provide sustainable solutions for complex health conditions. Sobi operates with a strong commitment to patient well-being and scientific excellence, striving to make a significant difference in the rare disease community.

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