ESTEVE GROUP – Medical Drug Safety Manager at Global Level

Departamento/ Department: Global Drug Safety & Pharmacovigilance
Ámbito funcional/ Area: Global Scientific and Medical area
Centro de trabajo/ Job Site: Torre Esteve
Versión/ Review: 1.0

Contacto: Nerea Martínez. Tel.: 677276073. nmartinez@esteve.com

Código de Documento: MDSM

CONTENIDO FUNCIONAL/ FUNCTIONAL CONTENT

Misión / Main Role

Protecting and improving patient care and safety in relation to the use of medicines and all medical and paramedical interventions
Promoting the safe, rational and effective use of medicines
Promoting education, understanding and training in Pharmacovigilance (PV)
Evaluating the benefit, harm, efficacy and risk of medications, carrying out continuous benefit-risk evaluations of medicines
Ensuring compliance with PV obligations under current legislation on the safety of medicines and PV.
Maintaining a robust PV system for the performance of the PV activities for all the medicinal products of Esteve Group.

Funciones / Roles

MEDICAL DRUG SAFETY MANAGER

Medical Review and Quality check of suspected adverse drug reactions (ADRs) and serious adverse events (SAEs).
Review / Preparation of Periodic Safety Update Reports (PSURs), safety documents for renewals and Risk Management Plans (RMPs), expert reports and Development Safety Update Reports (DSURs).
Assessing, defining and implementing, where necessary, the PV activities or risk minimization measures for company products.
Assessment of signals for company products either marketed or under investigation. Continuous safety profile review along life-cycle of the company products.
Collaboration in PV audits and inspections.
Medical assessment and elaboration/review of the Company Core Safety Information (CCSI) defined as relevant for the company.
Review and elaboration of safety sections and Reference Safety Information of the Investigator Brochure and labellings, in collaboration with Global Clinical Development department. For already marketed products: review of the safety sections of the product information in collaboration with Medical Affairs.
Review of clinical study protocols from the PV point of view.
Review of clinical study reports (safety section) and safety section of the regultary dossiers.
Managing external PV providers.
Updating and maintenance of the Pharmacovigilance System Master File – PSMF.
Preparation, review and updating of Standard Work Procedures (SOPs) and Working Instructions (WIs) applicable to the drug safety and PV department.
Medical surveillance of health products, cosmetics, and food supplements.
Support to any request for information from the competent authorities on drug safety.
Participation in project teams for the preparation of dossiers for new drug authorizations or new developments of already authorized products.
Contributing to the maintenance of an adequate file.
Participation in due-diligence of new products/companies.
Promoting and complying with the applicable regulations (for example GVP, GCP, data privacy), operating regulations in general as well as the procedures in the systems regarding the prevention of occupational risks and the environment, with the prior and relevant training in the field. All this while ensuring the maintenance of the confidentiality and security of the information.
Participating in Scientific Steering Committees and Scientific Advisory Meetings with Competent Authorities.

ENTORNO ORGANIZATIVO/ ORGANIZATION CHART & JOB RELATIONSHIPS

Superior directo/ Line Manager

Global Drug safety & Pharmacovigilance Head /
EU/UK QPPV
Healthcare professionals/Patients
EMA/MHRA/Other Regulatory Authorities
Regional PV centers in Spain
Ethic Committees and Investigators
Asociación de Médicos de la Industria Farmacéutica Española (AMIFE)
Farmaindustria/other pharmaceutical associations
CRO: Clinical Research Organisation

Reporte directo/ Direct Reporting

NA

Superior directo/ Line Manager

Global Drug safety & Pharmacovigilance Head /
EU/UK QPPV

PERFIL PROFESIONAL/ JOB PROFILE

Formación requerida/ Required Studies