Pharmacovigilance Advisor

Detalles de la oferta

Pharmacovigilance Advisor Location: Bogotá, Colombia Type of role: Permanent / Full time About the job We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? In this Role Will serve as the local PV contact for the authorities, accountable for PV inspections, and can be nominated as local Qualified Person for Pharmacovigilance (QPPV) or local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation. Work together with the Country safety head. Main Responsibilities: Ensure compliance with GPV policies for all Global Business Units when applicable, as well as with the local PV regulations for Colombia. Organize, implement and maintain a local PV system. Coordinate the availability and implementation of local PV unit resources, training, systems/procedures and tools. About you Experience & knowledge: Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended. A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary. Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus. Experience with Regulatory Agency interactions is a plus. Competencies: Strong knowledge and expertise in international and national (Pharmacovigilance) regulations as well as industry standards. Sufficient ability to interpret clinical data including safety data. Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important. Demonstrate problem-solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure. Ability to work in international and transversal teams. Education: Medical Doctor, Pharmacy Doctor, Pharmacist, Physician. Health Sciences PhD, MPH or master's degree. Language: English- Advanced (Excluding). Pursue Progress. Discover Extraordinary. Progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. #J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

Requisitos

Auxiliar De Enfermería Engativá 12 Horas Domingo A Domingo

Somos una IPS que presta servicios de medicina intramural, (terapia física, respiratoria, ocupacional, fonoaudiología, médico y enfermerías domiciliarias) ac...


Bogotá D. C.

Publicado a month ago

Urgente Auxiliar De Enfermeria Tripulante Ambulancia

Empresa de salud requiere de carácter urgente para su equipo de trabajo Auxiliares de Enfermería con experiencia mínimo seis meses como tripulante de ambulan...


Bogotá D. C.

Publicado a month ago

Auxiliar De Enfermería Con Moto

Se solicita Auxiliar de enfermería que tenga moto para realizar curaciones en el domicilio, debe ser organizado, con excelente presentación y servicio al cli...


Bogotá D. C.

Publicado a month ago

Ejecutivosconsultores Comerciales Sector Farmaceutico 3..Bogota

EMPRESA LIDER EN EL SECTOR FARMACEUTICO EN IMPORTACION Y COMERCIALIZACION DE MEDICAMENTOS, REQUIERE EJECUTIVOS COMERCIALES Y DE CUENTA PARA ATENCION EN EL SE...


Bogotá D. C.

Publicado a month ago

Built at: 2024-12-23T08:01:53.760Z