Experienced Safety Medical Writers

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 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. Working at Novo Nordisk At Novo Nordisk, 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.