Manager, Global ICSR Management

Accountabilities:

• • Oversee ICSR triage, case processing, in-line quality control, workflow management, and timely completion of safety activities in accordance with internal and external requirements.
  • Lead and monitor SAE reconciliation between safety and clinical databases, ensuring completion, identifying discrepancies, and resolving or escalating issues.
  • Establish, monitor, and analyze quality, compliance, productivity, and volume KPIs, partnering with process excellence teams to identify root causes and implement corrective actions.
  • Drive continuous improvement initiatives across ICSR management, including process optimization, productivity enhancements, automation, and technology efficiency initiatives.
  • Review workflow and case prioritization, balance team workloads, and ensure operational targets and regulatory timelines are consistently achieved.
  • Make decisions on escalated operational issues and contribute to the development and improvement of policies, SOPs, work instructions, and procedural documentation.
  • Support audit and inspection readiness and serve as a subject matter expert during audits and regulatory inspections.
  • Communicate pharmacovigilance agreement and contract information to relevant teams and contribute to vendor and CRO-related activities.
  • Lead or participate in cross-functional projects and represent ICSR Management expertise across broader organizational initiatives.
  • Deliver training and onboarding support for new team members, maintain training materials, monitor onboarding progress, and provide feedback to leadership.
  • Execute safety database study configuration testing when required and support initiatives designed to strengthen operational quality and compliance.
  • Mentor team members, support their professional development, contribute to recruitment activities, and take on team leadership responsibilities across global sites as needed.

  Requirements

  • Bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, another healthcare discipline, or an equivalent combination of education and relevant professional experience; an advanced degree is preferred.
  • At least 5 years of experience in drug safety, pharmacovigilance, or relevant clinical operations, including experience providing or supporting training.
  • Strong knowledge of global pharmacovigilance and regulatory requirements, including ICH, GVP, FDA requirements, GCP, NMPA/CDE requirements, and regulations applicable to individual and aggregate safety reporting.
  • Experience supporting pharmacovigilance reporting requirements involving regulatory authorities such as FDA, EMA, MHRA, CDE/NMPA, and other national competent authorities.
  • Hands-on understanding of ICSR case processing activities, including data intake, triage, coding, narrative development, follow-up, due diligence, and database management.
  • Experience working with Argus Safety or comparable safety databases, along with strong proficiency in Microsoft Office tools such as Excel, PowerPoint, and related digital platforms.
  • Strong understanding of clinical concepts, therapeutic-area patient populations, and relevant drug classes.
  • Demonstrated ability to manage projects, prioritize competing demands, and consistently deliver accurate, high-quality work within strict timelines.
  • Experience overseeing team deliverables and representing functional responsibilities during audits, inspections, and compliance activities.
  • Excellent written and verbal English communication skills; fluent English is required, and all application materials should be submitted in English.
  • Strong analytical, problem-solving, organizational, and decision-making skills, with exceptional attention to detail.
  • Ability to work effectively across cultures and time zones within a global organization.
  • A collaborative, inclusive, results-oriented mindset, combined with initiative, adaptability, continuous learning, and a strong sense of ownership.
  • Willingness to travel approximately 5% of the time.

  Benefits

  • Remote work opportunity based in Brazil.
  • Full-time position within a global, fast-growing pharmaceutical and biotechnology environment.
  • Opportunities to work on high-impact pharmacovigilance activities supporting patient safety.
  • Professional development and continuous learning opportunities.
  • Exposure to global regulatory requirements, cross-functional projects, audits, inspections, and process excellence initiatives.
  • Opportunities to mentor colleagues and contribute to team development and leadership initiatives.
  • Collaborative, multicultural work environment with colleagues across multiple regions.
  • Opportunity to influence operational processes, quality standards, productivity, and technology-enabled improvements.
  • Employee-focused culture emphasizing teamwork, excellence, innovation, inclusion, and continuous improvement.
  • Compensation and additional benefits are subject to the partner company's applicable employment terms and local policies.