Novo Nordisk

Experienced Safety Medical Writers

Fuldtid

Permanent

Vandtårnsvej 108, 2860 Søborg, Danmark

SE PÅ KORT

ID: 2713968

Indrykket for 6 dage siden

Are you on the lookout for an exceptional role giving you insights into the entire product portfolio of one of the world’s leading pharmaceutical companies with R&D-driven history of innovation and best-in-class medicines?

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 and use your expertise to ensure patient safety and best practice.

Become a part of our unprecedented growth journey. Apply today for a life-changing career!

The position
We are seeking experienced Safety Medical Writers to lead a range of tasks of high complexity and criticality related to safety data reporting.

In this position, you will have the opportunity to:

Be responsible for the preparation of complex aggregate safety reports, Risk Management Plans (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 across functions and markets, gaining extensive insights into the entire Novo Nordisk value chain

Act as an expert for junior team members, share information, and take proactive steps to excel in your role

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site work in Søborg, Denmark where our team is based.

Qualifications
You could be our ideal candidate, if you have:

A master’s degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological), combined with proven experience working within pharmacovigilance and medical writing

Excellent analytical competencies and experience in working with large datasets

Solid understanding of pharmacovigilance and of drug development in general

Expert understanding of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) and RMPs, and the guidelines and regulations that drive their preparation

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

Experience in submissions of Marketing Authorisation Applications will be considered an advantage.

To succeed in this role you have 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.

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 Novo Nordisk’s products (both currently marketed and under development worldwide), to ensure patient safety.

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