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Local Medical Safety Internship
Johnson & Johnson · Madrid, Madrid · Posted 3 days ago
Job Function: Career Programs
Job Sub Function: Non-LDP Intern/Co-Op
Job Category: Career Program
All Job Posting Locations: Madrid, Spain
Job Description: About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Essential Job Duties and Responsibilities 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.
Principal responsibilities:
Case Management (CM) Activities support 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.
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This role centers on Pharmacovigilance, Local Language Fluency, and English Fluency. There are 1,974 open roles at Johnson & Johnson right now.
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