Hybrid Safety & PV Specialist II

7050 INC Research Clinical Services Mexico Limited, S.A. de C.V.; Ciudad de México; Híbrido; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Syneos Health in Mexico is seeking a Safety & PV Specialist II to support pharmacovigilance operations in a hybrid environment. The role involves data entry, safety tracking, and narrative reporting across safety databases for expedited and regulatory reports.

The position focuses on enter/validate ICSR data, safety management planning support, and coordination with data management to ensure quality safety data across clinical and safety databases.

Responsabilidades

• Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• May assist in the preparation of the project plans such as Safety Management Plan.
• May perform set-up, delivery and close-out of safety and pharmacovigilance projects.
• Processes IC
• SRS
• Designed
• Triages IC
• Evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications, and tests.
• Compiles complete narrative summaries.
• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Coordinates with data management staff concerning the reconciliation of safety data between the clinical and safety databases.

Descripción del empleo

Syneos Health in Mexico is seeking a Safety & PV Specialist II to support pharmacovigilance operations in a hybrid environment. The role involves data entry, safety tracking, and narrative reporting across safety databases for expedited and regulatory reports.

The position focuses on enter/validate ICSR data, safety management planning support, and coordination with data management to ensure quality safety data across clinical and safety databases.