Senior Specialist, Global ICSR Management in Brazil at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Specialist, Global ICSR Management based in Brazil.

This is a fully remote opportunity for an experienced pharmacovigilance professional supporting global individual case safety report (ICSR) management.
The role covers end-to-end activities including case triage, processing, quality control, and safety data reconciliation.
You will help ensure that safety information is complete, accurate, compliant, and submitted within required regulatory timelines.
The position offers exposure to cases from clinical trials, post-market sources, literature, and other reporting channels.
You will work across global regulatory requirements and collaborate with internal teams, vendors, and CRO partners.
The role also provides opportunities to contribute to process improvements, decision-making, and team training.
It is well suited to a detail-oriented professional who combines strong scientific knowledge with sound judgment and a results-driven mindset.

• Independently perform ICSR triage, case processing, and quality control activities across clinical trial, post-market, spontaneous, solicited, and literature sources.
• Ensure individual case safety reports meet completeness, accuracy, quality, compliance, and submission requirements for regulatory authorities and other stakeholders.
• Conduct SAE reconciliation between safety and clinical databases, tracking completion against internal and external timelines.
• Identify, investigate, resolve, and escalate discrepancies or issues arising during SAE reconciliation and case management activities.
• Consistently meet quality, compliance, productivity, and volume KPIs while maintaining high standards of case processing.
• Apply operational policies, standard operating procedures (SOPs), and work instructions (WIs) when making process-related decisions.
• Contribute to problem solving and continuous improvement initiatives within global ICSR management processes.
• Execute ICSR-related activities in accordance with applicable pharmacovigilance agreements and contracts when working with vendors or CROs.
• Support onboarding by delivering training to new team members and developing or updating training materials.
• Provide feedback to management regarding onboarding progress and help resolve or escalate issues affecting new team members.
• Collaborate effectively with internal stakeholders and external partners while supporting timely and compliant safety operations.

• Bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, another healthcare-related discipline, or an equivalent combination of relevant education and professional experience.
• Advanced education or specialized training in global patient safety or pharmacovigilance is preferred.
• At least 2 years of experience in drug safety, pharmacovigilance, or relevant clinical environments, including appropriate training.
• Strong understanding of global pharmacovigilance and regulatory requirements, including ICH, GVP, FDA 21 CFR 312.32 and 314.80, GCP, and applicable requirements from authorities such as EMA, MHRA, FDA, and NMPA/CDE.
• Practical knowledge of ICSR case management processes, including data intake and acquisition, triage, medical coding, narrative development, quality control, and due diligence.
• Experience with Argus Safety or comparable safety databases and related pharmacovigilance platforms.
• Proficiency with Microsoft Office tools, particularly Excel and PowerPoint; familiarity with Visio and other digital tools is a plus.
• Fluent English, with excellent written and verbal communication skills. Applications and CVs should be submitted in English.
• Strong analytical and problem-solving abilities, with sound judgment and attention to detail.
• Effective time management and the ability to prioritize competing activities while consistently meeting deadlines.
• Results-oriented, proactive, collaborative, adaptable, and committed to continuous learning and process improvement.
• Ability to communicate clearly, provide constructive feedback, work inclusively, and collaborate effectively across global teams.
• Previous experience in the pharmaceutical or biotechnology industry is preferred.

• Fully remote work arrangement based in Brazil.
• Full-time employment opportunity.
• Opportunity to work in a global pharmacovigilance and patient-safety environment.
• Exposure to international regulatory requirements and ICSR workflows across multiple safety data sources.
• Opportunities to develop expertise in global drug safety, regulatory compliance, and process excellence.
• Professional development through training, knowledge sharing, and involvement in continuous improvement initiatives.
• Collaborative international environment focused on scientific excellence, patient safety, innovation, and teamwork.
• No travel requirement specified for the position.