GERENTE FARMACOVIGILANCIA

Role Summary

GERENTE FARMACOVIGILANCIA

Responsibilities

• Serve a Haleon PV Ops (Pharmacovigilance Operations), Single Case Processing global safety database SME contributing to the development, implementation, launch and maintenance of the global safety database with critical attention to the program's success, while ensuring global case management activities align with Haleon standards for PV processing;
• Generate PV Ops (Pharmacovigilance Operations), SCP (Single case processing) operative policies, procedures, trainings and relevant instructional materials for the global safety database worldwide users in compliance with worldwide regulations and industry standards to safeguard against inspection findings;
• Deputize the Senior Manager Pharmacovigilance Single Case Processing, Knowledge Center in case of an inspection or partner audit;
• Support the development and continuous improvement of the global safety database as workstream content contributor and support backlog grooming sessions, iterative review of requirements (user stories, data requirements, mappings and other decisions relevant to PV SCP (Pharmacovigilance Single Case Processing);
• Assess training delivery needs and develop training storyboards that will be created and uploaded to the learning management system by Quality and Document Control;
• Identify target training audiences applicable to procedural documents and mapped to training curriculum;
• Create processes that ensures quality and compliant oversight with case management PV processes and regulatory submission activities for HSI from all sources worldwide in order to meet regulatory compliance with authorities and PV standards, including but not limited to CIOMS, ICH, GVP, FDA, EMA, MHRA, PMDA;
• Lead cross-functional training of relevant stakeholders;
• Participate in special projects as assigned.

Qualifications

• Bachelor’s degree in a scientific or medically related field;
• Solid knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, clinical safety documentation, local regulatory requirements, and pharmacovigilance methodology; understanding of world-wide pharmacovigilance regulatory requirements; other consumer health areas nutritionals, cosmetics and devices a plus;
• Demonstrated pharmacovigilance/clinical safety or related experience;
• Direct experience working with outsourced providers;
• Demonstrated project management skills and prioritize competing priorities;
• Knowledge of principles of data collection, manipulation and retrieval;
• Knowledge of principles of data collection, manipulation and retrieval and experience summarizing data;
• In-depth understanding of medical and drug terminology and coding (MedDRA, IMDRF, etc.).