At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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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.

Local Medical Safety (LMS) Activities support

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.

Minimum Qualification

• Education: Pharmacy or Life Sciences.
• Fluency in local language(s) and in the English language is required.
• Strong organizational skills, attention to detail and accuracy are important.
• Creativity, thinking outside of the box.
• Acquires knowledge of Global, Regional and Local PV Procedural Documents as applicable.

We Offer:

• Duration of the internship -  1 year
• Full time
• Location : Madrid

Required Skills:

Preferred Skills:

The anticipated pay range and benefits for this position is: