Local Medical Safety Internship

Johnson & Johnson; Madrid; In loco; EUR 10.000 - 15.000; Tempo pieno

Vantaggi offerti da questo lavoro

1 year internship

Full-time internship

Madrid location

Descrizione del lavoro

Johnson & Johnson is seeking a Pharmacovigilance Trainee for a 1-year internship in Madrid. The role reports to the Country Safety Head and supports Safety and Risk-Benefit activities at the Local Operating Company level.

Responsibilities include collecting and processing adverse events, follow-ups, translation of documents, ICSR submission oversight, literature searches, and maintaining archives per retention schedules.

Competenze

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

Mansioni

• 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.
• Collection, triage, evaluation and processing of all AEs, AE/PQC and SS (ICSR) within the Global Safety System from various sources.
• Follow-ups for missing information and/or requests by GMS.
• Translation of source documents, including EudraVigilance downloads.
• Reconciliation activities and oversight of ICSR submission to regulatory authorities.
• Literature search and related activities; local archive management and document retention.

Conoscenze

Fluency in local language(s)

Fluency in English

Formazione

Pharmacy or Life Sciences

Descrizione del lavoro

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.

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

Case Management (CM) Activities support

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:

• 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 ICSR 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

• 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

The anticipated pay range and benefits for this position is:

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.