Senior Specialist, Global ICSR Management

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

📋 Description

• Independently assess and prioritize individual case safety reports (ICSRs).

• Manage and conduct quality control for ICSRs sourced from clinical trials, post-market spontaneous and solicited sources, literature, and other origins.

• Guarantee completeness, accuracy, quality, compliance, and adherence to regulatory submission deadlines.

• Perform reconciliation of Serious Adverse Events (SAE) between safety and clinical databases.

• Monitor reconciliation processes, address or escalate issues, and fulfill internal and external deadlines.

• Achieve quality, compliance, productivity, and volume key performance indicators (KPIs).

• Recognize and implement continuous improvement initiatives within ICSR management.

• Make process-related decisions that align with operational policies, standard operating procedures (SOPs), and work instructions.

• Carry out ICSR activities in accordance with pharmacovigilance agreements and contracts with vendors/CROs.

• Provide training to new team members and develop or update training materials as needed.

• Offer onboarding feedback and assist in issue resolution or escalate matters to the line manager.

⛳️ Requirements

• Proficiency in English is mandatory.

• A minimum of a bachelor's degree in life sciences, clinical medicine, nursing, pharmacy, another healthcare profession, or an equivalent combination of relevant education or professional experience.

• At least 2 years of experience in drug safety/pharmacovigilance or relevant clinical experience, including training.

• Familiarity with global regulatory requirements, such as ICH, GVP, FDA 21 CFR 312.32 and 314.80, GCP, NMPA requirements, and other international regulations.

• Knowledge of pharmacovigilance ICSR capture and submissions to regulatory authorities including FDA, CDE/NMPA, EMA, MHRA, and others.

• Understanding of databases and case processing tasks, including data acquisition/intake, triage, coding, narrative construction, and due diligence.

• Exceptional verbal and written communication skills.

• Strong problem-solving abilities.

• Effective time management skills.

• Results-oriented with a keen attention to detail.

• Experience with Argus Safety database is required.

• Proficient in MS Office suite, including Excel, PowerPoint, and Visio.

• Preferred digital skills.

🏝️ Benefits

• Equal opportunity employer with nondiscrimination protections.

• Comprehensive training and onboarding support.

• Opportunities for continuous learning.

• Collaboration within a global team.