Local Medical Safety Internship

• Duration of the internship - 1 year
• Full time

Dado que esta posición se publica en un pais sujeto a los requisitos de transparencia salarial de la EU, el equipo de Adquisición de talentos proporcionara información sobre el rango salarial a petición y a los candidatos invitados a una entrevista.

Job Function: Career Programs

Job Sub Function: Non-LDP Intern/Co-Op

Job Category: Career Program

The Pharmacovigilance Trainee provides support to the Country Safety Head, LSO back-up and Local Medical Safety Specialist in all administrative aspects of Safety and Risk-Benefit Management and Reporting at the Local Operating Company level.

Provide support to the Local Safety Unit (LSU) and Case Management Network for the following activities, during the transition period and as applicable:

• Collection, triage, evaluation and processing of all AEs, AE/PQC and SS (ICSR) within the Global Safety System obtained from all sources (spontaneous, solicited/RRAs, clinical trials, literature and other potential sources).
• Follow-ups attempt for ICSR with missing information and/or information requested by GMS.
• Translation of source documents in local language, including cases download from Eudravigilance as requested.
• Reconciliation activities
• Oversight of ICSR submission to regulatory authorities of all initial and follow-up ICSRs according to local regulations and perform quality checks when applicable.
• Literature search and other related activities.
• Local archive management, ensuring documents generated in the daily pharmacovigilance activities, such as ICSR case documentation, are archived properly and according to the company retention schedules and privacy requirements.

Provide support to the CSTL, CSTL backup and LSS in the following activities under the LMS scope, including:

• Preparation of safety insights materials
• Involvement in product and disease scientific training
• Implementation of RMPs and ARMAS/CARMAS
• Submission and tracking of Aggregate Reports
• Activities related to PV Safety training, including AEPQC training
• Preparation of compliance and safety metrics
• Implementation of new/revised safety regulations
• Maintenance of day to day activities and regulatory compliance and responsibilities at Local Operating Company Level, including adequate record management.
• Other LMS activities under LMS RACI responsibilities as required.

All Job Posting Locations: Madrid, Spain

• Location : Madrid