The Position
As a Safety Medical Writer at Novo Nordisk, you will:
- 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.
- Contribute to the evaluation and implementation of changes in local/global guidelines to ensure compliance with internal and external requirements.
- Drive process improvement activities, medical writing competency development and skill building across Safety Surveillance Reporting.
- Act as an expert for junior team members, share information, and take proactive steps to excel in your role.
Qualifications
We are looking for candidates with the following qualifications:
- A master’s degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological), combined with proven experience at least 8+ years 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 handling documents of high complexity (e.g., submissions of Marketing Authorisation Applications) or prior experience in performing specialist tasks will be considered an advantage.
Apply: https://careers.novonordisk.com/job/Bangalore-Senior-safety-medical-writer-Karn/1151759701/https://careers.novonordisk.com/job/Bangalore-Senior-safety-medical-writer-Karn/1151759701/
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