stillingsbetegnelse:
Senior Safety Surveillance Medical Writer in Global Safety

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Are you an experienced safety medical writer with process expertise in preparation of development safety update reports (DSURs) and periodic safety update reports (PSURs)? Do you like to be at the forefront of driving regulatory guidance in our processes? Do you build strong relationships with key internal stakeholders and excel at knowledge-sharing? Join us as a Senior Safety Medical Writer and put these skills into action to help ensure patient safety and best practice. About the department Safety Surveillance Reporting is an international team of writers based in Denmark and India. We are responsible for planning and preparing high quality scientific documents (PSURs, DSURs and risk management plans) that are compliant with regulatory guidelines. These documents are essential to provide ongoing transparent reporting, evaluation and management of the safety profiles of all Novo Nordisk products (before and after marketing) and ensure patient safety. We work in multi-disciplinary teams, interacting with representatives from all major functions across Novo Nordisk. The position This job provides a unique opportunity to combine your pharmacovigilance experience and knowledge of relevant regulatory guidelines to set direction for periodic aggregate safety reports in a changing regulatory environment. You will be responsible for providing expert advice on preparation of PSURs and DSURs across projects, giving you visibility and opportunity to drive process change. You will train of writers in the regulatory guidelines and preparation of PSURs and DSURs. There will also be opportunity to be involved in ad-hoc writing assignments that will use your project management, collaborative skills and creativity. Qualifications You have a biological science, pharmaceutical, medical degree or PhD (MSc, MSc Pharm, MD, PhD or equivalent) and =3 years relevant experience of medical writing, with experience in patient safety/pharmacovigilance. You should have in-depth knowledge and understanding of relevant regulatory guidelines. You must have a strong background and insight into safety during drug development and pharmacovigilance, combined with an ability to provide guidance and advice on future strategy for the Global Area. You are energetic and passionate in relation to your job. You have excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally. You have strong planning, and project management skills. You are able to prioritise tasks and rise to challenges. You are fluent in English (please apply in English), both written and spoken, and you are an experienced user of MS Office (Excel, PowerPoint, Word, Outlook). Working at Novo Nordisk At Novo Nordisk, you will join a patient-centred culture of talented professionals. We respect individuality and encourage you to make the most of your potential. Contact For further information, please contact Mark White at +45 3079 6710. Deadline 11 July 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark