Senior Specialist, Global ICSR Management

BeiGene, Ltd.; Brasil; Remote; BRL 120,000 - 180,000; Full time

Job summary

BeOne is seeking a Senior Specialist, Global ICSR Management in Brazil (remote). The role independently triages and processes ICSR cases, ensures data quality and regulatory submissions, and performs SAE reconciliation between safety and clinical databases to meet internal and regulatory deadlines.

Requirements include a life sciences degree, 2+ years in pharmacovigilance, strong communication, and proficiency with Argus and MS Office. Remote work option from Brazil with global responsibilities.

Qualifications

• Bachelor’s degree in life sciences, clinical medicine, nursing or pharmacy; advanced degree preferred.
• Minimum 2 years in drug safety/pharmacovigilance or relevant clinical experience.
• Understanding of global regulatory requirements for pharmacovigilance reporting (ICH, GVP, FDA rules) is required.
• Experience with case processing activities (data intake, triage, coding, narrative construction).
• Excellent verbal and written communication; strong time management and attention to detail.

Responsibilities

• Manage ICSR case workflows (triage, case processing, QC) across sources.
• Perform SAE reconciliation between safety and clinical databases.
• Meet quality/compliance and productivity KPIs and implement continuous improvements in ICSR processes.
• Deliver training and onboarding for new team members; update training materials.
• Support issue resolution and escalation with line manager as needed.

Skills

Communication

Problem solving

Time management

Detail orientation

Team collaboration

Education

Bachelor’s degree in life sciences/healthcare

Advanced degree preferred

Tools

Argus safety database

MS Office

Excel

PowerPoint

Visio

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 Senior Specialist, Global ICSR Management independently executes the triage of individual case safety reports (ICSRs) to ensure initial assessment of cases is in line with processes and regulations. The Senior Specialist, Global ICSR Management independently executes the case processing and quality control of individual case safety reports (ICSRs) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholders. The Senior Specialist performs SAE reconciliation between the safety and clinical databases. The Senior Specialist is responsible for performing tasks in adherence to internal and external timelines and meeting quality, compliance and productivity target metrics, support decision making and provide training.

Essential Functions

ICSR Case Management Activities: Upon successful completion of the core ICSR case management curriculum and targeted training for Triage and Case processing tasks under a mentor's supervision, team members will independently manage the tasks. After achieving the required baseline quality results, the Senior Specialist will be eligible to handle all the workflows (Triage, Case processing, QC) based on case workload and business need from all sources (e.g. clinical trials, post-market spontaneous and solicited sources, literature, etc.) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholders. SAE Reconciliation: Perform SAE reconciliation between safety and clinical databases. Track SAE reconciliation to ensure completion and adherence to internal and external timelines and resolve or elevate issues with SAE reconciliation. Quality and Compliance Indicators: Meet quality/compliance KPI or metrics. Productivity and Process Excellence: Meet productivity/volume KPI or metrics. Demonstrate problem solving capabilities and execute continuous improvement opportunities within ICSR management. Decision Making: Make process decisions consistent with operational policies, SOPs and WIs. Vendor/CRO Management: Execute ICSR related activities as described in PV Agreements/Contracts following instruction. 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 elevate to line manager for new team members.

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.
• Minimum 2 years' experience in drug safety/pharmacovigilance or relevant clinical experience, including training required.
• Understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities.
• Understanding of databases, case processing activities, including data acquisition/intake, triage, coding, narrative construction and due diligence activities.
• Excellent communication skills (verbal and writing).
• Strong problem-solving skills.
• Effective time management skills.
• Results oriented and strong attention to detail.

Supervisory Responsibilities

N/A

Travel

N/A

Computer Skills

Argus safety database and other platforms required, MS Office suite, Excel, PowerPoint, Visio, digital skills are preferred.

Global Competencies

• 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

Company Values

Patients First Driving Excellence Bold Ingenuity Collaborative Spirit

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.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.