Manager, Global ICSR Management

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Supervise triage, case processing, and maintain in-line quality control for individual case safety reports.

• Track, define, and establish metrics for efficiency, quality, compliance, productivity, and volume.

• Analyze and address issues through root cause analysis, late case investigations, and implementing corrective actions.

• Oversee and enhance SAE reconciliation between safety and clinical databases.

• Review workflow and prioritize case processing to adhere to internal and external deadlines.

• Balance the team’s workload to ensure achievement of target KPIs.

• Make decisions on escalated operational policies, SOPs, and work-instruction matters.

• Propel changes to processes and procedures and assist in the creation of procedural documentation.

• Support audits and inspections as a subject matter expert and carry out readiness activities.

• Manage vendor/PV agreement information and assist with CRO-related tasks.

• Lead or take part in cross-functional ICSR projects and initiatives focused on process excellence.

• Provide training, develop training materials, and facilitate onboarding for new team members.

• Conduct study configuration testing in the safety database as required.

• Mentor team members, offer development opportunities, and contribute to staff recruitment initiatives.

⛳️ Requirements

• Proficient in English communication is essential.

• A minimum of a bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, or another healthcare discipline, or equivalent relevant education/professional experience.

• At least 5 years of experience in drug safety/pharmacovigilance or relevant clinical roles, including training.

• Strong grasp of global regulatory standards, encompassing ICH, GVP, FDA 21 CFR 312.32 and 314.80, GCP, NMPA requirements, and PAL of PRC.

• Familiarity with pharmacovigilance individual case safety report and aggregate safety report submissions to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory bodies.

• Competence in safety databases and case processing, including data acquisition/intake, triage, coding, narrative construction, and due diligence.

• Clinical insight into patient populations within therapeutic areas and drug classifications.

• Experience in project management and time management techniques.

• Capability to oversee team deliverables and represent functional responsibilities during audits and inspections.

• Exceptional verbal and written communication abilities.

• Strong analytical and problem-solving skills, results-driven mindset, and keen attention to detail.

• Awareness of global cultural nuances.

• Proficiency in Argus Safety database and other relevant platforms is required.

• Knowledge of Microsoft Office suite, including Excel, PowerPoint, and Visio.

• Willingness to travel approximately 5% of the time.

• An advanced degree is preferred.

🏝️ Benefits

• Equal opportunity employment.

• Travel requirement: 5%.

• Collaborative global team environment.

• Opportunities for professional growth and development.

• Comprehensive training and onboarding support.