Senior Pharmacovigilance Associate — Remote

Visa Hunt; México; A distancia; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a Senior Associate, Pharmacovigilance to manage SAE data and safety reporting for large studies. You will draft Safety Management Plans, review SAE data for accuracy, enter data into safety databases, and generate queries to resolve missing information.

Responsibilities include QC of SAEs, preparing regulatory safety submissions, and collaborating with global teams to ensure compliance with international guidelines.

Formación

• Excellent understanding of medical and scientific terminology and ADR assessment
• Excellent understanding of international regulations and reporting requirements
• Strong computer literacy and data extraction capability
• Excellent written and verbal communication skills
• Excellent organizational skills and ability to handle multiple priorities
• Ability to work independently in a matrix team environment

Responsabilidades

• Author Safety Management Plan for assigned studies
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and related tracking
• Generate queries for missing or unclear information and follow-up with sites
• Perform QC of SAEs processed by other PV Associates
• Generate regulatory reports and safety submissions as needed

Conocimientos

Medical terminology

Pharmacovigilance knowledge

Regulatory knowledge

Data extraction

Stakeholder communication

Organizational skills

Educación

Bachelor’s degree in a science-related field or nursing

Herramientas

MS Office (Excel, PowerPoint, Word)

Descripción del empleo

Worldwide Clinical Trials is seeking a Senior Associate, Pharmacovigilance to manage SAE data and safety reporting for large studies. You will draft Safety Management Plans, review SAE data for accuracy, enter data into safety databases, and generate queries to resolve missing information.

Responsibilities include QC of SAEs, preparing regulatory safety submissions, and collaborating with global teams to ensure compliance with international guidelines.