- Opening for Safety Medical Writer
- Are you looking for a role as Safety Medical Writer?
- Join our company Global Service center to have a life changing career!!!
About the department
- The department the Global Service Center 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.
- The job is a permanent position.
- 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 specialist expertise and project management.
- Plan, drive, and co-ordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs.
- Contribute to continuous resource planning process in collaboration with immediate superior – including identifying medical writing tasks and assist in prioritization of tasks
- Perform consistency review of documents as back-up SMWAct as mentor/trainer for other safety medical writers working with the product, as required.
- 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)Responses to any safety questions raised in connection with assessment reportsInput 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
- Medical Doctor, Dental doctor, Master degree in pharmacy or equivalent medical and scientific background.
- 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.).
- Open and honest
- Systematic and organised
- Goal oriented
- Good team playerGood at sharing knowledge