Drug Safety Manager at GE Healthcare

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalIndustries

Requirements

Expert knowledge of pharmacovigilance regulations, guidelines, company SOPs, and conventions
Expert knowledge of safety profile of company products
Experience in global case processing of Individual Case Safety Reports (ICSR) from post-marketing, clinical trials, and published literature
Ability to perform accurate coding of MedDRA terms, preparation of case narratives, and review of expedited reports
Proficiency in safety database functionality, case processing conventions, and workflow tasks
Skills in compliance root cause analysis, CAPA development, SOP review/revision, and process improvement
Ability to troubleshoot issues, provide guidance based on regulatory requirements and Data Handling Conventions
Capability to lead team meetings, prepare agendas, minutes, and track storage
Experience in vendor oversight, training, and quality monitoring
Knowledge of metrics collection, gap analysis, KPI tracking, and continuous improvement planning
Ability to serve as subject matter expert during inspections, audits, and as liaison to internal/external groups
Skills in pharmacovigilance support for clinical trials, aggregate reports, database projects, and user acceptance testing
Effective time management for complex projects and individual project planning
Ability to maintain and ensure availability of organization charts, job descriptions, CVs, and training records

Responsibilities

Oversight of all global case processing activities (Intake, Triage, Data Entry, Medical Review, Quality Control/Finalization, Distribution, due diligence/follow-up) for drug/device reports from all sources, ensuring accuracy and timeliness
Manage GPV case processing mailbox: assign emails, perform daily checks, respond to inquiries
Assign cases in safety database and distribute work based on priorities and workload for optimal resource allocation
Perform workflow tasks as needed, including MedDRA coding, case narratives, and expedited report reviews, per GPV processes and regulations
Provide oversight, mentoring, peer advising, and coaching to team on case processing and product knowledge
Troubleshoot team questions/issues on database, conventions, and submissions; provide guidance
Lead team meetings, prepare agendas, track/store minutes
Oversee vendors: collaborate with external leaders, develop solutions, provide training, monitor quality
Support Manager/Director with metrics collection/tracking, gap analysis, continuous improvement plans to meet KPIs and ensure compliance
Provide root cause analysis and CAPA to Compliance for late submissions; re-train team and update processes
Initiate/drive process improvements via updates to Work Instructions, SOPs, and guidance documents
Serve as pharmacovigilance SME for case processing during inspections/audits
Act as liaison/resource to internal/external groups (e.g., Regulatory Affairs, Medical Affairs, QA, Clinical Development, CROs) on case processing/reconciliation
Act as liaison between local LSU and global teams for domestic case issues
Provide PV support for clinical trials: request configurations, develop study-specific job aids
Support preparation/submission of aggregate reports
Participate in database projects and user acceptance testing as case processing SME
Contribute to complex projects, manage time, develop individual project plans
Maintain expertise in PV regulations, guidelines, SOPs, conventions, and product safety profiles
Ensure availability of current organization charts, job descriptions, CVs, and training records for safety personnel
Provide PV trainings to local staff and business partners upon request
Support local response to safety-related issues

Skills

ICSR processing

MedDRA coding

case narratives

GPV processes

safety database

SOP review

root cause analysis

process improvement

regulatory compliance

quality control

workflow management

team oversight

troubleshooting

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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