Job Title: Associate Project Manager, Patient Safety
Location: Shanghai, China
Category: Clinical
Job ID: 254618
The Associate Project Manager, Patient Safety, oversees project-specific Patient Safety Solutions (PSS) operations, managing the full adverse event (AE) process from clinical trials and post-marketing sources. The role ensures timely, accurate, and compliant safety reporting, provides leadership and mentorship to project teams, and maintains high-quality service to internal and external stakeholders.
Project Leadership & Management
Lead global or regional projects, ensuring harmonized communications and processes.
Monitor and manage project workflow to meet deadlines and ensure compliance with safety reporting regulations, SOPs, and departmental guidelines.
Make decisions regarding AE reporting within project-specific guidelines.
Provide oversight for all PSS activities, ensuring regulatory and contractual compliance.
Monitor deliverables against contract assumptions, identify out-of-scope work, and prevent budget overruns.
Contribute to Time and Cost Estimates for PSS business.
Adverse Event Processing & Oversight
Oversee receipt and processing of AE reports (spontaneous or clinical trial).
Ensure data entry, AE review, narrative writing, MedDRA coding, and listedness assessments are completed accurately.
Ensure appropriate medical review and follow-up for missing information.
Prioritize expedited reporting to clients, regulatory authorities, ethics committees, investigators, and internal stakeholders.
Oversee Expedited Safety Reports (ESRs) and endpoint reporting.
Maintain knowledge of safety database conventions and system functionality.
Quality Assurance & Compliance
Conduct routine quality reviews of AE reports and aggregate reports.
Oversee EudraVigilance activities and ensure compliance with global regulatory standards.
Participate in signal detection, trend, and pattern recognition activities.
Prepare Safety Management Plans (SMPs), Reconciliation Plans, and other project-specific safety plans.
Contribute to the development and review of SOPs, Work Instructions (WIs), and departmental guidance.
Prepare for audits and inspections, ensuring quality and regulatory compliance.
Training, Mentorship & Communication
Train and mentor project team members and less experienced colleagues in AE processing and PSS operations.
Cascade information from internal and external meetings to PSS management and colleagues.
Attend client meetings, provide oversight, and maintain strong client relationships.
Prepare and deliver safety presentations for investigators, clients, and internal stakeholders.
Additional Responsibilities
Supervise workloads and individual performance of junior team members.
Manage the review of cumulative safety data for DSMBs, regulatory authorities, or clients.
Coordinate Safety Committees, endpoint committees, and data reconciliation with Data Management or clients.
Contribute to Clinical Trial Protocols, Case Report Forms, and AE Reporting forms.
Perform additional duties as assigned.
Minimum Required
Education and experience options:
Non-degree: 6–7 years Safety experience
Associate degree: 5–6 years Safety experience
Associate degree RN: 5–6 years Safety experience
BS/BA: 4–5 years Safety experience
MS/MA: 2–3 years Safety experience or 3–4 years relevant experience
PharmD: 1–2 years Safety experience or 2–3 years relevant experience (1-year residency/fellowship may count)
Degree preferred in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry
Experience & Skills
Compliance with client and global regulatory requirements.
Knowledge of worldwide pharmacovigilance regulations and guidelines, GCP, ICH guidelines, and medical/drug terminology.
Experience with AE/SAE processing, database management, narrative writing, and regulatory submissions.
Leadership and mentorship skills; ability to anticipate and resolve problems.
Knowledge of aggregate reporting, risk management, and pharmacovigilance regulatory environment.
Good verbal, written, and presentation skills.
Financially intuitive and able to manage project budgets.
EudraVigilance certification preferred.
Knowledge of Medical Device Reporting desirable.
Office-based environment
Travel: 10–15% (may include overnight stays)
Pharmacovigilance
Patient Safety Solutions
AE/SAE Reporting & Oversight
Safety Project Management
Signal Detection & Trend Analysis
Regulatory Compliance
EudraVigilance
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