ESPECIALISTA DE FARMACOVIGILANCIA

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We are searching the best talent for Pharmacovigilance Specialist   to be in Ciudad de México - México Prepare and ensure timely submission of Aggregate Reports, Pharmacovigilance Reports.
Elaborate Risk Management plans (RMPs) according to local regulations & global procedures and take the appropriate actions for the implementation and follow up of additional activities for the Pharmacovigilance Plan and/or Risk Minimization Plan.
In collaboration with and Global Clinical Operations / Medical Affairs Operations department provide reports to the Health Authority of the on-going clinical trials and Post Authorization Safety Studies (PASS), as appropriate.
PV systems compliance Ensure communication & accurate follow up with Global Clinical Operations (GCO & GCO MAO) to follow PV local regulations regarding clinical trials conducted in the territory as applicable, including those carried out by third parties, as per the contracts & agreements.
Accountable for the preparation and/or supervision of vital outlines, status reports, graphs, charts, tables, and slides for periodic reviews with the LSO or Safety Head locally.
Monitor data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.
.
patient support programs, market research studies, marketing activities, internet sites, surveys, etc.), as applicable.
Audit / inspection preparation and support Assist inspectors / auditors and support document requests in case of internal/external audits.
Preparation of self-identified CAPAs for PV system non-conformances identified.
Close connection with LOC departments including but not limited to Medical Affairs, Business Quality, Business Intelligence, Marketing and Sales, participating in projects, meetings and business reviews/issue management teams as the need arrises, providing technical input.
Components of the LSO role may be delegated to the PV Specialist as back-up, with appropriate training/documentation ensuring that the overall requirements are met and when no other position in the LSU is available.
Qualifications A degree in life of pharmaceutical, health sciences, medical degree or equivalent is preferable.
Knowledge and understanding of key legislation applicable to pharmacovigilance within Mexico and Good Pharmacovigilance Practices.
Excellent verbal and written communication skills Proven expertise and experience in Pharmacovigilance regulations and Sanitary Regulation processes is desirable Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
Ability connect with internal and external customers Proficiency in English language is required