Job Description

　　Primary Job Function:

　　The Global Safety Database Specialist will play a vital role in ensuring the safety and well-being of patients by maintaining and supporting the Global Safety Database and associated systems. The Specialist will be a key member of the Global Pharmacovigilance (GPV) department, responsible for supporting its business needs as a leader in the area of safety systems. Additionally, the Specialist will contribute to project teams by utilizing technical skills to define and build solutions, ensuring that safety data is captured accurately and efficiently.

　　Core Job Responsibilities:

　　Responsibilities include but are not limited to:

　　Ensuring the Global Safety Database and associated systems are maintained and supported while complying with regulatory requirements and company policies.

　　Collaborating with cross-functional teams to identify business requirements and developing solutions that meet their needs.

　　Providing technical support, training, and troubleshooting for users of the Global Safety Database and associated systems.

　　Participating in the implementation of new systems and upgrades to ensure they meet the needs of business stakeholders, including the GPV department, local Affiliate Safety Representatives worldwide, and other Abbott divisions, particularly Abbott Nutrition.

　　Acting as a subject matter expert and liaison between business stakeholders, Abbott IT, and software vendors, ensuring all parties are aligned on system requirements and timelines, and promptly addressing and resolving any issues.

　　Ensuring timely and accurate data entry, coding, and reporting of adverse events in the Global Safety Database.

　　Developing and maintaining standard operating procedures (SOPs) for the Global Safety Database and associated systems and updating them as needed to reflect changes in regulatory requirements or business needs.

　　Maintaining knowledge of applicable regulations, including ICH, GVP, and local national regulations, and ensuring compliance with all requirements.

　　Participating in audits and inspections related to the Global Safety Database and associated systems and ensuring that any findings are addressed promptly and effectively.

　　Providing support for pharmacovigilance activities as needed and actively seeking opportunities to improve processes and systems to enhance patient safety and product quality.

　　Key Skills:

　　Attention to detail

　　Strong problem-solving skills

　　Critical thinking skills

　　Excellent communication and interpersonal skills

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]