Senior Specialist, Global ICSR Case Processing & Quality Control

BeOne Medicines; São Paulo; Híbrido; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

An innovative firm is seeking a Senior Specialist in Global ICSR Case Processing & Quality Control to ensure the accuracy and compliance of individual case safety reports. This role involves managing case processing, conducting quality checks, and enhancing productivity through continuous improvement initiatives. The ideal candidate will possess a strong background in drug safety, excellent communication skills, and a detail-oriented mindset. Join a company committed to diversity and inclusion, where your expertise will contribute to vital healthcare advancements.

Qualificações

• 2+ years in drug safety or relevant clinical experience.
• Knowledge of global regulatory requirements (ICH, GVP, FDA, EMA).

Responsabilidades

• Manage case processing and quality control of ICSR reports.
• Perform SAE reconciliation and maintain compliance with standards.

Conhecimentos

Drug Safety

Pharmacovigilance

Communication Skills

Problem-Solving

Time Management

Formação académica

Bachelor’s Degree in Life Sciences

Advanced Degree (preferred)

Ferramentas

Argus

MS Office

Digital Tools

Descrição da oferta de emprego

Senior Specialist, Global ICSR Case Processing & Quality Control

Join BeOne Medicines as a Senior Specialist, Global ICSR Case Processing & Quality Control.

Location: Sao Paulo (Hybrid)

Language Requirements: Portuguese and English required; Spanish is a plus.

Experience: 2+ years in pharmaceutical/biotech industry, hematology, or oncology.

Role Overview

The Senior Specialist independently manages case processing and quality control of individual case safety reports (ICSRs), ensuring completeness, accuracy, and compliance with regulatory standards. Responsibilities include SAE reconciliation, supporting decision making, training, and maintaining quality and productivity metrics.

Key Responsibilities

1. ICSR Case Processing: Execute case processing and QC activities from various sources to meet quality standards for regulatory submissions.
2. SAE Reconciliation: Perform reconciliation between safety and clinical databases, ensuring timely resolution of issues.
3. Quality & Compliance: Achieve KPIs related to quality and compliance standards.
4. Productivity & Process Improvement: Meet volume KPIs and identify continuous improvement opportunities.
5. Decision Making: Make process decisions aligned with SOPs and policies.
6. Vendor Management: Follow PV agreements for ICSR activities.
7. Training & Onboarding: Deliver and develop training materials, support new team members.

Minimum Requirements

• Bachelor’s degree in life sciences, medicine, nursing, pharmacy, or related field; advanced degree preferred.
• At least 2 years of experience in drug safety/pharmacovigilance or relevant clinical experience.

Additional Qualifications

• Knowledge of global regulatory requirements (ICH, GVP, FDA, EMA, NMPA, etc.).
• Experience with databases and case processing activities.
• Excellent communication, problem-solving, and time management skills.
• Attention to detail and results-oriented mindset.
• Global cultural awareness and PV operational knowledge.

Other Details

No supervisory responsibilities. Computer skills required include Argus, MS Office, and digital tools. Global competencies include teamwork, feedback, initiative, adaptability, and communication.

BeOne Medicines is an equal opportunity employer committed to diversity and inclusion.