Safety Medical Writing Specialist

Do you want to play a key role in ensuring patient safety by applying your expertise as a pharmacovigilance communicator? Do you build strong relationships with stakeholders and enjoy putting plans into action? If so, then join us as a Safety Medical Writer Specialist and use your expertise to ensure patient safety and best practice.
Apply today!

The position
We are currently in the process of expanding our clinical activities and are seeking a Safety Medical Writer Specialist to lead a range of specialist tasks of high complexity and criticality. As a Safety Medical Writer Specialist at [xxxxx], you will have the opportunity to:

Lead a range of specialist tasks related to safety data reporting, including the preparation of complex aggregate safety reports, RMPs, and responses to Health Authority questions.

Collaborate with cross-functional teams, including Clinical Development and Regulatory Affairs, to ensure high-quality scientific writing and timely reporting of safety data.

Establish close partnerships and interactions with colleagues, gaining extensive insights into the entire Novo Nordisk value chain.

Take on responsibilities, share information, and take proactive steps to excel in your role.

Qualifications
You demonstrate a passion for our purpose and an eagerness to drive change. Your ethical compass and strong sense of responsibility ensure that you have a dedicated and influential presence. You are driven to excel and inspire others to do the same.
You thrive in a multicultural environment of continuous development, and you are excellent at establishing contact, communicating, collaborating with colleagues, as well as challenging them. You have outstanding planning, and project management skills. You are analytical and able to present in a structured, clear, and accurate way.
Additionally, you have:

A master’s degree in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological), preferably complemented by a PhD.

Proven experience working within pharmacovigilance and medical writing.

Solid understanding of pharmacovigilance and of drug development in general.

Expert understanding of PSURs, DSURs and RMPs, and the guidelines and regulations that drive their preparation.

Experience in working with large datasets and have excellent analytical competencies.

Fluency in both written and spoken English (the business language) and solid experience using MS Office

About the department
Safety Medical Writing is a department within Global Safety, and is situated in Søborg, Denmark and Bangalore, India. Global Safety is an organisation of more than 400 highly professional people with a high level of education within Life Sciences. Safety Medical Writing is responsible for reporting on the emerging safety profile based on routine surveillance of all [xxxxx]’s products (both currently marketed and under development worldwide), to ensure patient safety.

Working at [xxxxx]
At [xxxxx], we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.

Contact
For further information, please contact Mette Krøger Hare via email [xxxxx]

Deadline
30 June 2024.

Please include a few sentences about why you are applying for this position in your CV. You do not need to attach a cover letter to your application. At [xxxxx], we are committed to an inclusive recruitment process and equality of opportunity for all job applicants. To ensure a fair recruitment process, please refrain from adding a photo to your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.