Sr. Drug Safety Specialist

Shanghai - China

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

Additional Information

Relocation Assistance Provided: No

Required Experience:

Senior IC

Job Description SummaryPrimarily 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...