Pharmacovigilance Lead: SAE Data & Safety Reporting

Worldwide Clinical Trials; Ciudad de México; Presencial; MXN 871.991 - 1.726.543; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking an Associate in Pharmacovigilance to oversee SAE data collection, evaluation, and reporting for studies of varying complexity. You will lead safety activities with support from senior staff and ensure data integrity and regulatory compliance.

The role requires a science background, at least 1 year in pharmacovigilance, strong communication, and proficiency with MS Office. Domestic/international travel may be needed as projects demand.

Formación

• Bachelor’s degree in a science-related field or nursing.
• Minimum of 1 year pharmacovigilance experience (pre-approval trials).
• Strong MS Office skills and attention to detail.
• Excellent written and verbal communication; ability to multitask.

Responsabilidades

• Author Safety Management Plan for assigned studies.
• Review SAE data for completeness and accuracy.
• Enter data in Safety Database and track safety information.
• Generate queries and follow up with sites for resolution.
• Perform QC of SAEs processed by other PV staff.
• Prepare regulatory reports and safety submissions as needed.

Conocimientos

Medical terminology

Pharmacovigilance knowledge

Organization skills

Communication skills

Team collaboration

English fluency

Educación

Bachelor's degree in science or nursing

Herramientas

MS Office (Excel, PowerPoint, Word)

Descripción del empleo

Worldwide Clinical Trials is seeking an Associate in Pharmacovigilance to oversee SAE data collection, evaluation, and reporting for studies of varying complexity. You will lead safety activities with support from senior staff and ensure data integrity and regulatory compliance.

The role requires a science background, at least 1 year in pharmacovigilance, strong communication, and proficiency with MS Office. Domestic/international travel may be needed as projects demand.