Local Medical Safety Internship (Pharmacovigilance Trainee)
jj · Madrid
Descripcion del puesto
About the role
Johnson & Johnson is offering a one-year full-time Local Medical Safety internship in Madrid, within its Career Programs. The Pharmacovigilance Trainee supports the Country Safety Head, the Local Safety Unit (LSU) and the Local Medical Safety Specialist in the administrative aspects of Safety and Risk-Benefit Management and Reporting at the Local Operating Company level.
Key responsibilities
- Support the LSU and Case Management Network: collect, triage, evaluate and process adverse event reports (AEs, AE/PQCs, SS) and ICSRs from spontaneous, solicited, clinical trial and other sources
- Follow up ICSRs with missing or requested information and translate source documents into the local language, including downloads from EudraVigilance
- Oversight of ICSR submissions to regulatory authorities and quality checks, literature searches, and proper archiving of daily PV records
- Prepare safety insight materials, take part in product and disease scientific training, and implement RMPs, ARMAS and CARMASS
- Submit and track aggregate reports, prepare compliance and safety metrics, and implement new or revised safety regulations
- Maintain day-to-day regulatory compliance and record management at local level
Required profile
- Education in Pharmacy or Life Sciences
- Fluency in the local language and in English
- Strong organisational skills, attention to detail and accuracy
- Creativity and ability to think outside the box
Required skills
- Knowledge of Global, Regional and Local pharmacovigilance procedural documents
- Preferred: familiarity with ICSR handling and regulatory reporting
What we offer
- One-year full-time internship
- Salary range provided on request to invited candidates
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jj
Madrid
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