stillingsbetegnelse: Safety Surveillance Specialist

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Are you interested in drug safety and pharmacovigilance writing? Do you have a passion for safety, and relevant insight and experience from the pharmaceutical industry that you feel will benefit ensuring patients safety? Then we definitely want to hear from you! About the department Safety Surveillance Reporting is responsible for aggregate safety reporting on the surveillance of adverse reactions reported for marketed products and products under development at Novo Nordisk A/S. We are a dynamic, well-functioning, international team of 10 Safety Medical Writers and 6 Safety Publishers, and 8 Safety Data Analysts. We work together to coordinate, prepare, and electronically publish all key safety surveillance reporting documents. As we work in a rapidly changing regulatory landscape, where the global requirements for reporting on pharmacovigilance activities are still evolving, change-readiness and out-of-the-box thinking are both invaluable assets. The job As a Safety Medical Writer Specialist in Safety Surveillance Reporting at Novo Nordisk A/S, your primary responsibility will be to ensure continued focus and development of competencies within the field of pharmacovigilance writing and risk-benefit communication. With your previous experience, you will be expected to contribute with expertise on addressing and communicating evaluations and findings regulatory documents and replies to authorities. As part of your role, you will also review and provide constructive input for key documents prepared in Safety Surveillance. You will typically work in close collaboration with the Director of Safety Surveillance Reporting and the Safety Surveillance management team. You will also prepare the key safety reporting documents (including Development Safety Update Reports, Periodic Safety Update Reports, and Clinical Risk Management Plans) in collaboration with Safety Surveillance Advisors, Medical Specialists from Global Development, Medical Advisors from Medical Affairs, Project Managers from Regulatory Affairs, and Safety Publishers) especially for documents of high complexity and critical to project(s) and strategic area. Finally, you will be expected to actively contribute to continual process improvements and other improvements projects. Qualifications You have a university degree (MD, PhD, MSc or equivalent), =5 years experience from the pharmaceutical industry, and significant experience with medical writing and medical communication in English (publications and regulatory documents). You should have in-depth knowledge and understanding of the pharmaceutical industry, understanding of the R&D value chain, and understanding of regulatory processes and requirements. You must have a strong medical background and insight into safety during drug development and pharmacovigilance. Experience with training, supervising and mentoring in thee core competencies is essential. On a more personnel level, you should have strong project management and inter-personal skills, be good at planning, coordinating, reaching consensus, and most importantly a passion for clear and effective communication. You are thorough, structured and conscientious, and you have a good sense of humour. Experience with LEAN or similar is an advantage for contributing to continuous process improvement. At Novo Nordisk A/S, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Mark White on +45 3079 6710. Deadline 18 May 2015.

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