The Associate Specialist, Pharmacovigilance will support the execution of activities associated with the Mexico Local ICSR Transition and Operational Stabilization Project. Under the supervision of the Country PV Lead or designated delegate, the incumbent will contribute to the implementation, stabilization and monitoring of local pharmacovigilance processes while ensuring compliance with applicable company procedures and local regulatory requirements.
Key Responsibilities
- Support implementation and stabilization of local Individual Case Safety Report (ICSR) management activities transferred to the Mexico affiliate, including acknowledgements, follow-up, translations and submissions according to local regulations and company procedures.
- Assist in the documentation, monitoring and continuous improvement of local case management processes required during the transition and stabilization phase.
- Support compliance monitoring activities, including tracking of key quality and timeliness metrics related to ICSR processing and reporting obligations.
- Assist in the preparation, maintenance and archival of pharmacovigilance documentation required to support project deliverables and local regulatory compliance.
- Support pharmacovigilance inspections, audits, issue management and corrective action activities associated with project objectives and compliance requirements.
- Contribute to implementation and maintenance activities related to Risk Management Plans (RMPs), aggregate safety reports, Post-Approval Safety Monitoring Programs (PSMPs) and other assigned pharmacovigilance deliverables, as required.
- Support translation and quality control of pharmacovigilance documents required for regulatory submissions and project activities.
- Participate in cross-functional initiatives, process harmonization activities and project-related deliverables that contribute to successful implementation of the local operating model.
- Complete all required training
📌 Regional Pharmacovigilance Associate (Ciudad de México)
🏢 Msd
📍 Ciudad de México
Postulate a este anuncio
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.