Job FunctionProduct SafetyJob Sub FunctionPharmacovigilanceJob CategoryPeople LeaderLocationMexico City, MexicoRegulatory ComplianceEnsure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance.Accountable internally for ensuring that the LOC meets procedure defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.Oversight responsibilities of case processing operational activities delegated to the Center of Excellence Case Processing hub for Latin America or external vendor as appropriate.Case processing activities include but not limited to Inbound reporting, outbound reporting, translation of AEs/Special Reporting Situations/PQCs, literature search, due diligence.Accountable for compliance monitoring for submissions to Competent Authorities (HAs).
Reconcile compliance data provided and take appropriate corrective actions as defined by...