Sr. Drug Safety Specialist

Job Description Summary
Primarily responsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. Additionally, as a more advanced case processor, responsible for activities that support training, compliance, regulation changes, and the shaping of process improvements.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description
Essential Responsibilities

• Receive, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature
• Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines
• Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives
• Identify missing or discrepant information and perform active case follow-up via verbal or written contact
• Review expedited reports for submission to regulatory authorities and ethics committees
• Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., Regulatory Affairs, Medical Affairs, Quality Assurance, clinical development teams, CROs, etc.)
• Perform reconciliations between clinical, quality and PV databases
• Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed
• Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed
• Serve as pharmacovigilance resource and subject matter expert during inspections and audits
• Vendor oversight as needed, collaborating with external project leaders and teams to develop solutions, provide appropriate training, and monitor quality
• Provide oversight of clinical trials, requesting study configurations and developing study-specific job aids, as needed.
• Oversee workflow management and case prioritization to maintain compliance with regulatory timelines
• Provide Compliance group with root cause analysis and CAPA for late submissions
• Troubleshoot questions and issues with team, including database functionality, case processing conventions, and report submission failures; provide guidance based on experience and Data Handling Conventions
• Assist with writing and updating of SOPs and other guidance documents, in response to process improvements or changing regulations
• Participate in database projects and user acceptance testing, as needed, providing insight from business user / case processing perspective

Qualifications/Requirements

• Minimum of 3 years in pharmaceutical/biotechnology industry with experience in Pharmacovigilance including clinical trials and post-marketing.
• Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review, expedited report review and scheduling, and follow-up with reporters.
• Strong understanding of Safety Database functionality and business workflow to be able to perform root cause analyses and troubleshoot
• Confidence in decision-making, taking into consideration data handling conventions, but also industry expectations and regulations
• Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
• Demonstrated ability to train and coach PV personnel
• Demonstrated ability to manage own workload, prioritize, plan and organize assignments and work within strict timelines
• Understanding of Microsoft Office applications, specifically Excel and Word

Desired Characteristics

• Healthcare professional with clinical experience preferred.
• Experience with Argus preferred.
• Demonstrated initiative, teamwork, and accountability
• Demonstrated ability to manage and independently drive projects to completion, in addition to overseeing day-to-day case processing needs

Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

**Additional Information*
*Relocation Assistance Provided:
No