M Pharma Safety Medical Writer Post @ Novonordisk
M Pharma Safety Medical Writer Post @ Novonordisk. Career @ Novonordisk. M pharma jobs. Pharmacy jobs. Check out all the details for the same below:
Job Title: Safety Medical Writer
Work Location: Banglore
Department: Global Safety department within the Global Service Centre responsible for processing ICSRs and for performing Safety Surveillance activities. Global safety has an outstanding track-record in case processing and writing/publishing aggregate reports. You will join a team of highly motivated employees, responsible for the safety of the patients.
Eligibility: Master degree in pharmacy or equivalent medical and scientific background.
Experience: Medical Doctor, Dental doctor, and experience with scientific writing in English (publications or equivalent) Specific personal and job-related demands (communication skills, ability to take initiative, flexible attitude, ability to work independently/in a team, personal traits necessary in the job, etc.). You should be open and honest, systematic and organized, proactive, goal oriented and be a Good team player.
Job Description: The job is a permanent position and starts ASAP – latest 01-JUL-2018. You will become a member of the safety surveillance team which is responsible for aggregate reporting. You will especially focus on defining and integrating user/stakeholder requirements and safety risk management. You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within a specialist domain and project management. You will also plan, drive, and coordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs, perform medical writing tasks in Safety Surveillance including planning and preparation of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans (RMPs), perform consistency review of documents as backup SMW and act as mentor/trainer for other safety medical writers working with the product, as required, prepare responses to any safety questions raised in connection with assessment reports. You will contribute to continuous resource planning process in collaboration with immediate superior – including identifying medical writing tasks and assist in prioritisation of tasks and provide input to investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs), and investigational medicinal product dossiers (IMPDs) and other relevant ad-hoc documents.