Hybrid PV & Safety Specialist II (Mexico)

Syneos Health; México; Híbrido; MXN 420.000 - 540.000; Jornada completa

Descripción de la vacante

Syneos Health in Mexico City is seeking a Safety & PV Specialist II to support pharmacovigilance activities in a hybrid role. You will enter information into PVG systems, help prepare Safety Management Plans, and assist in project set-up and close-out for safety projects.

The role involves triaging ICs, evaluating ICSRs for completeness and regulatory reporting, data entry into safety databases, coding events, compiling narratives, and coordinating with data management to reconcile safety data,

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 safety plans.
• Triages ICs, 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 reconciliation of safety data between the clinical and safety databases.

Descripción del empleo

Syneos Health in Mexico City is seeking a Safety & PV Specialist II to support pharmacovigilance activities in a hybrid role. You will enter information into PVG systems, help prepare Safety Management Plans, and assist in project set-up and close-out for safety projects.

The role involves triaging ICs, evaluating ICSRs for completeness and regulatory reporting, data entry into safety databases, coding events, compiling narratives, and coordinating with data management to reconcile safety data,