Experienced Pharmacovigilance Writer

ALK-Abelló A / S; Madrid; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

Una empresa farmacéutica líder busca un Escritor de Farmacovigilancia para unirse a su equipo en Madrid. Este puesto clave implica redactar informes de seguridad agregados y gestionar la comunicación sobre el perfil beneficio-riesgo de los productos post-comercialización. El candidato ideal tendrá un título en Medicina o Ciencias Naturales y al menos 3 años de experiencia en farmacovigilancia. Disfrutarás de un entorno de trabajo dinámico y colaborativo, donde podrás influir activamente en el desarrollo de productos y contribuir a la seguridad de los pacientes. ¡Aplica hoy y forma parte de este equipo comprometido!

Servicios

Cafetería para desayuno y almuerzo

Ambiente de trabajo dinámico

Oportunidades de desarrollo personal y profesional

Política de trabajo remoto

Formación

• 3 años de experiencia en la redacción de informes de seguridad agregados.
• Sólidos conocimientos de conceptos médicos y procesos de enfermedad.

Responsabilidades

• Planificar y supervisar informes de seguridad agregados.
• Colaborar con actividades interfuncionales y comunicar con partes externas.

Conocimientos

Escritura de informes de seguridad agregados

Colaboración

Comunicación efectiva

Conocimientos de conceptos médicos

Gestión del tiempo

Educación

Grado universitario en Medicina o Ciencias Naturales

Herramientas

MS Office

Descripción del empleo

Do you want to play a key role giving your insights into the entire product portfolio of the world’s leading pharmaceutical companies within allergy treatments?

Would you like to join a dedicated and empowered team in Global Safety & Pharmacovigilance as a Pharmacovigilance Writer in a growing company? Apply today!

The position

Pharmacovigilance Spain is a department within Global Safety & Pharmacovigilance, and we are a team of enthusiastic and skilled professionals responsible for local and global pharmacovigilance activities. You will primarily focus on writing aggregate safety reports, along with planning, conducting safety data analysis, and managing documents, while being responsible for communicating the benefit-risk profile of ALK’s post-marketing products.

Your tasks include:

• Plan and keep oversight of aggregated safety reports
• Lead kick-off meetings, manage communication and data requests
• Write aggregated safety reports
• Write risk management plans and responses to health authority questions if needed
• Collaborate with and participate in cross-functional activities
• Communicate with external parties

You will work independently and in collaboration with the highly skilled Safety Surveillance team and other colleagues across the functional areas in Research & Development at ALK. Our setup allows for great variety in daily tasks and interactions with many stakeholders across the company. It is a role with significant responsibility, allowing for the opportunity to develop, contribute and make an impact.

What you bring

To be a success in this role, you have a background in medical / natural sciences, a solid understanding of medical concepts, and the ability to keep focus on both details and the big picture. We are driven by a high level of professionalism, collaboration, and an open-minded approach, where everyone contributes to an inspiring and fun working environment.

We expect that you have:

• A university degree within Medicine or Natural Sciences (MD, DVM, MSc Pharm or equivalent)
• 3 years of direct experience writing aggregate safety reports such as Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), or other similar documents
• A solid understanding of medical concepts, disease processes, scientific methodology, and drug development
• Experience within pharmacovigilance, including roles focused on safety monitoring, signal detection, and reporting to authorities.
• Understanding regulations and guidelines from agencies such as the EMA or FDA in relation to aggregated reports is required.
• Ability to work independently in a global and continuously developing environment.
• A strong collaborator who is ethical, responsible, and works well under pressure when needed
• A self-driven and strong communicator
• Fluency in both written and spoken English (business language) and solid experience using MS Office

Become a part of ALK

In Global Safety & Pharmacovigilance, we provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company in progress, whose headquarters is located in Denmark, offering unique job opportunities, such as being involved in an international environment due to the close collaboration with the headquarters although the position is located in Madrid.

The flat structures in ALK attract independent individuals who enjoy being close to the decision-making process. We consider our pioneering spirit coupled with our trustworthiness our winning formula. Our offices in Madrid offer a dynamic and pleasant work environment allowing good conciliation between personal and work life. You will be part of an engaged and informal team who values skill and knowledge creation, where you will be able to actively influence and challenge the status quo.

The position is located at ALK’s site in Madrid, which is in the business area of Ciudad Lineal, very close to the center of Madrid. We have quick access to the Hermanos García Noblejas and Ascao metro stations and we also have a wide bus connection. The manufacturing center is located at Calle Miguel Fleta 19 while the Business Support area is in an annex building located in the Avalon Business Park. Nevertheless, we have a remote working policy that will allow you to work from home part of your time.

ALK, among other benefits, has a canteen where employees can have breakfast and lunch every day.

How to apply

Please click on apply and attach a letter of motivation and CV. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

If you want to know more about the position, before submitting your application, please don’t hesitate to contact Senior Manager, Begoña Gandarias at.

We are looking forward to hearing from you!