Job Description

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Senior safety medical writer
Category: Clinical Development
Location:
Bangalore, Karnataka, IN
Department: Safety Surveillance, Global Patient Safety.
Are you passionate about ensuring patient safety through meticulous scientific writing? Do you have the expertise to handle complex safety surveillance reporting? We are looking for experienced Safety Medical Writers to join our team and lead high-complexity tasks related to safety reporting. If this sounds like you, read on and apply today for a life-changing career.
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.

About the department
Safety Medical Writing is a global team within Global Patient Safety, situated in Bangalore, India and Sxc3xb8borg, Denmark. Global Patient Safety is an organization of more than 400 highly professional people with a high level of education within Life Sciences. Safety Medical Writing is responsible for reporting on the emerging safety profile based on routine surveillance of all Novo Nordisk's products (both currently marketed and under development worldwide), to ensure patient safety.
Working at Novonordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing.
Contact
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).
Apply Now!
Deadline
27 December 2024.
Disclaimer
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.