Experienced Pharmacovigilance Writer

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 of in Global Safety & Pharmacovigilance as a Pharmacovigilance Writer in a growing company? Apply today

Pharmacovigilance Spain is a department within Global Safety & Pharmacovigilance, and we are a team of enthusiastic and skilled professionals that has responsibility 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 set up 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.

To be a success in this role, you have a background in medical/natural sciences, 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 continuous developing environment.
• A strong collaborator that 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

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 headquarter is located in Denmark, offering unique job opportunities, such as, to be involved in an international environment due to the close collaboration with the headquarter 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 what 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.

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 on Begona.GandariasZuniga@alk.net

We are looking forward to hearing from you