Manager, Global ICSR Management

BeiGene, Ltd.; Brasil; Remote; BRL 250,000 - 380,000; Full time

Job summary

BeOne is seeking a Manager for Global ICSR Management to lead triage, case processing and in-line quality control in GPS Safety Operations. This role supports governance, audits, and cross-functional projects from Brazil in a remote setting.

You will monitor KPIs, drive continuous improvement, and ensure timely, compliant handling of safety reports across programs and regions.

Qualifications

• Minimum bachelor’s degree in life sciences, clinical medicine, nursing or pharmacy.
• Advanced degree preferred.
• 5+ years in drug safety/pharmacovigilance or related clinical experience.
• Strong knowledge of global regulatory requirements (ICH, GVP, FDA rules).

Responsibilities

• Oversee ICSR case processing, triage, and quality control to ensure timely completion.
• Lead SAE reconciliation and monitor related timelines and accuracy.
• Develop and monitor quality/compliance KPIs with Process Excellence.
• Drive productivity and process improvements within ICSR Management.
• Represent GPS Safety Operations in audits and cross-functional projects.

Skills

Fluent English

ICSR Knowledge

Pharmacovigilance

Education

Bachelor's degree in life sciences/clinical medicine/pharmacy

Advanced degree preferred

Tools

Argus safety database

MS Office

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Language Requirement: Fluent English is Required

Preferred Experience: Pharmaceutical/Biotech Industry

Location: Brazil Remote

General Description: The Manager, Global ICSR Management oversees triage, case processing and in-line quality control focusing on efficiency, quality & compliance.

The Manager, in consultation with the Process Excellence team, is responsible for monitoring, defining, and setting metrics and determining course of action to resolve any issues.

The Manager has decision-making authority to clarify ICSR issues related to governance documents rising from the ICSR team.

The Manager will also represent GPS Safety Operations in cross functional projects related to ICSR activities, as needed.

The Manager will provide support, as needed, in audits and inspections.

Essential Functions

ICSR Case Management activities

• Monitor the activities of triage, case processing, and quality control of individual case safety reports (ICSR) to ensure timely completion of activities and assist with execution of activities if needed.

SAE Reconciliation

• Oversee, analyze, drive change to SAE reconciliation process.
• Support and assist with SAE reconciliation between safety and clinical databases.
• Track SAE reconciliation to ensure completion and adherence to internal and external timelines and resolve or escape issues with SAE reconciliation.
• Review SAE reconciliation plan.

Quality and Compliance Indicators

• Monitor quality/compliance KPI or metrics.
• Set and define quality/compliance KPI or metrics (with Process Excellence team).
• Generate metrics for quality and compliance to meet internal and external timelines.
• Analyze and resolve issues with quality/compliance KPI or metrics including root cause analysis, late case investigation and determining actions to correct issues.

Productivity and Process Excellence

• Monitor productivity/volume KPI or metrics.
• Set, define and generate productivity/volume KPI or metrics.
• Analyze and resolve productivity issues.
• Manage the execution of continuous improvement opportunities within ICSR Management with support from senior manager.
• Serve as business lead for process excellence, continuous improvement, productivity and technology efficiencies initiatives with support from senior manager.

Workflow Management

• Review ICSR in workflow to ensure completion of cases within internal and external timelines.
• Resolve or expedite case prioritization and case processing questions.
• Balance team workload and ensure target KPIs are met.

Decision Making, Process Evaluation & Documentation

• Make process decisions for escalated issues regarding operational policies, SOPs and WIs.
• Contribute to changing operational policies, SOPs and WIs.
• Analyze and drive changes to existing processes and procedures.
• Assist in creation of new procedural documents with support from senior manager.

Audit & Inspection Support

• Act as SME in audits and inspections with support from senior manager.
• Execute audit/inspection readiness activities.

Vendor/CRO Management

• Communicate signed PV Agreement/Contract information to team.

Cross-Functional Collaborations & Ad-hoc Requests

• Lead critical process or sub-process areas and project initiatives within GPS organization.
• May lead and/or participate as ICSR Management subject matter expert (SME) on cross functional projects (outside the GPS) organization as needed.

Training & Onboarding

• Deliver training to new team members.
• Develop and update training materials.
• Provide feedback to line manager for review about new team member onboarding status.
• Support resolving issues or escape to line manager for new team members.

Study configuration testing

• Execute Study configuration testing in safety database, as needed.

Minimum Requirements – Education and Experience

• Minimum bachelor’s degree (major in life sciences, clinical medicine, nursing, pharmacy) or other health care professional or the equivalent combination of relevant education or professional experience.
• Advanced degree preferred.

Other Experience

• Minimum 5 years' experience in drug safety/pharmacovigilance or relevant clinical experience, including training required.
• Strong understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR 312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports and aggregate safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities.
• Proficiency in databases, case processing activities, including data acquisition/intake, triage, coding, narrative construction and due diligence activities.
• Clinical knowledge of therapeutic area patient populations and drug class.
• Experience with effective project and time management strategies to provide high-quality deliverables on time.
• Ability to oversee team deliverables and to represent functional responsibilities in audits and inspections.
• Excellent communication skills (verbal and writing).
• Strong problem-solving skills.
• Results oriented and strong attention to detail.
• Global culture awareness.

Supervisory Responsibilities

• May take team lead responsibilities overseeing team deliverables and supervise staff across multiple GPS sites per business needs.
• Mentor team members.
• Provide growth and development opportunities.
• Contribute to staff recruitment.

Travel: 5%

Computer Skills: Argus safety database and other platforms required, MS Office suite, Excel, PowerPoints, Visio, digital skills are preferred.

#LI-Remote

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer.

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do that.

Patients First

Driving Excellence

Bold Ingenuity

Collaborative Spirit