Job Title: Specialist II, Patient Safety Solutions
Location: Shanghai, China
Category: Clinical
Job ID: 254268
The Specialist II, Patient Safety Solutions supports Clinical Safety and Pharmacovigilance operations, managing the full adverse event (AE) process, including safety data from clinical trials and post-marketing sources. The role ensures timely, accurate, and compliant processing and reporting of safety data to clients and regulatory authorities, while providing high-quality service to internal and external stakeholders.
Adverse Event Processing & Reporting
Manage receipt and processing of AE reports from spontaneous and clinical trial sources, including database entry, AE review, narrative writing, coding, follow-up for missing information, and listedness assessment against product labels (for marketed products, if applicable).
Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, vendors, and internal stakeholders within agreed timelines.
Prioritize cases requiring expedited reporting to worldwide regulatory agencies.
Prepare timely pharmacovigilance reports, including:
Individual Case Safety Reports (ICSRs)
Annual IND Reports
European Annual Safety Reports (ASRs)
Development Safety Update Reports (DSURs)
Periodic Reports, line listings, and aggregate reports
Quality Control & Database Management
Perform peer or independent quality control of safety reports as needed.
Reconcile safety databases in collaboration with Data Management or clients.
Maintain knowledge of Fortrea and client-specific database conventions.
Signal Detection & Trend Analysis
Assist in signal detection, trend, and pattern recognition activities.
Monitor workflow for assigned studies/programs to ensure timelines are met.
Documentation & SOP Compliance
Maintain understanding and compliance with Fortrea PSS SOPs, Work Instructions (WIs), and guidance documents.
Contribute to development or update of departmental WIs and SOPs.
Support preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans under supervision.
Training & Mentorship
Support and train less experienced safety staff in case handling, AE reporting, and other safety operations.
Provide input for monthly status reports and project metrics.
Client & Team Collaboration
Participate in project teams, client meetings, and liaise with clients as appropriate.
Assist with audit and inspection preparation.
Support review of cumulative safety data for submission to DSMBs, regulatory authorities, or clients.
Assist in coordinating endpoint committees and Safety Committees/DSMBs.
Other Duties
Make decisions regarding AE reporting within project guidelines.
Maintain positive PSS relationships across functional units.
Perform additional duties as assigned by management.
Minimum Required
Education and experience options:
Non-degree: 2–3 years safety experience or 5 years relevant experience
Associate degree: 2–3 years safety experience or 4 years relevant experience
BS/BA: 2 years safety experience or 3–4 years relevant experience
MS/MA: 2 years safety experience or 2–3 years relevant experience
PharmD: 2 years safety experience or 2–3 years relevant experience (1-year residency/fellowship may count)
Preferred Degree Disciplines
Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field
Strong verbal and written communication skills; good presentation skills
Team player with ability to work independently
High accuracy and attention to detail
Ability to interact and influence management, staff, and external contacts
Knowledge of medical and drug terminology, GCP, ICH guidelines, and global regulatory AE reporting requirements
Knowledge of medical device reporting desirable
Understanding of R&D processes and objectives
Good keyboard skills; familiarity with MS Office and Windows applications
Office-based environment
Pharmacovigilance
Clinical Safety
AE/SAE Reporting
Safety Reporting & Compliance
Signal Detection
Patient Safety Solutions
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