Pharmacovigilance Safety Specialist-00000L14
Description
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc, one of the Pharmaceutical Companies of Johnson & Johnson
We are looking for a Pharmacovigilance Safety Specialist for the Local Operating Company (LOC).
Main Responsibilities / Tasks:
The Pharmacovigilance Safety Specialist is an employee of the Local Operating Company (LOC) working for patient´s safety.
Major Responsibilities:
- Supporting the coordination of safety reporting requirements as required for Marketing Authorisation Holders(MAH) and/or study sponsor, as applicable.
- Responsible for the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Competent Authorities (CAs) and other potential sources.
- Assist with initial quality review and assessment of individual cases.
- Undertake site visits for special interest cases as requested by LSO and support in start up of clinical trials and local studies trainings to internal and external customers.
- Coordination of projects within the different LOC departments to support a proper safety flow for each type of project.
- Ensure availability as back-up for business and non-business hours contacts.
Calificaciones
Essential Knowledge & Skills
- Pharmacy, Medicine or Science related degree
- Sound knowledge of general medicine, or pharmacy, or clinical practice
- Awareness for and familiarity with industry principles of drug development and pharmacology
- Proficiency in global and local SOPs
- Computer literate with good knowledge of GMS database systems
- Good verbal and written communication skills
- Fluency in Spanish and English required
Travel Requirements: 1-5% domestic and possibly international travel
Ubicación principal: Europa/Oriente Medio/Africa-España-Comunidad de Madrid-Madrid
Organización: Janssen-Cilag S.A. (formerly Janssen Sp) (7300)
Elegible para reubicación No
Área: Compliance
Description
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc, one of the Pharmaceutical Companies of Johnson & Johnson
We are looking for a Pharmacovigilance Safety Specialist for the Local Operating Company (LOC).
Main Responsibilities / Tasks:
The Pharmacovigilance Safety Specialist is an employee of the Local Operating Company (LOC) working for patient´s safety.
Major Responsibilities:
- Supporting the coordination of safety reporting requirements as required for Marketing Authorisation Holders(MAH) and/or study sponsor, as applicable.
- Responsible for the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Competent Authorities (CAs) and other potential sources.
- Assist with initial quality review and assessment of individual cases.
- Undertake site visits for special interest cases as requested by LSO and support in start up of clinical trials and local studies trainings to internal and external customers.
- Coordination of projects within the different LOC departments to support a proper safety flow for each type of project.
- Ensure availability as back-up for business and non-business hours contacts.
Calificaciones
Essential Knowledge & Skills
- Pharmacy, Medicine or Science related degree
- Sound knowledge of general medicine, or pharmacy, or clinical practice
- Awareness for and familiarity with industry principles of drug development and pharmacology
- Proficiency in global and local SOPs
- Computer literate with good knowledge of GMS database systems
- Good verbal and written communication skills
- Fluency in Spanish and English required
Travel Requirements: 1-5% domestic and possibly international travel
Ubicación principal: Europa/Oriente Medio/Africa-España-Comunidad de Madrid-Madrid
Organización: Janssen-Cilag S.A. (formerly Janssen Sp) (7300)
Elegible para reubicación No
Área: Compliance