Senior Safety Medical Writer

8+ years

Not Disclosed

Bangalore

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: MSc./M. Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Title: Safety Medical Writer
Department: Safety Surveillance, Global Patient Safety
Location: [Specify Location]

About the Position

Are you passionate about ensuring patient safety through meticulous scientific writing? Do you have the expertise to handle complex safety surveillance reporting? We are seeking experienced Safety Medical Writers to join our team at Novo Nordisk, where you will lead high-complexity tasks related to safety reporting. If this sounds like you, read on and apply today for a life-changing career.

Key Responsibilities:

As a Safety Medical Writer at Novo Nordisk, your responsibilities will include:

Safety Reports & Risk Management: Prepare complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions.
Collaboration: Work with cross-functional teams, including Clinical Development and Regulatory Affairs, to ensure high-quality scientific writing and timely reporting of safety data.
Guideline Compliance: Contribute to the evaluation and implementation of changes in local/global guidelines to ensure compliance with internal and external requirements.
Process Improvement: Drive process improvement activities and contribute to the development of medical writing competencies within the Safety Surveillance Reporting team.
Mentorship: Act as an expert for junior team members, sharing knowledge and proactively helping to improve the team’s capabilities.

Qualifications:

We are looking for candidates who possess:

Educational Background: A master’s degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological sciences).
Experience: At least 8+ years of experience working within pharmacovigilance and medical writing.
Analytical Skills: Strong analytical competencies and experience working with large datasets.
Pharmacovigilance Knowledge: Deep understanding of pharmacovigilance, drug development, and safety reporting guidelines.
Expertise in Reports: Expert knowledge in preparing Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and RMPs and familiarity with the regulations that drive their preparation.
Language Skills: Fluency in written and spoken English (business language).
Technical Skills: Proficiency in MS Office and experience working with complex documents (e.g., submissions of Marketing Authorization Applications).

About the Department:

The Safety Medical Writing team is part of the Global Patient Safety division, with locations in Bangalore, India and Søborg, Denmark. The team is responsible for safety reporting on all of Novo Nordisk’s products, both marketed and in development worldwide. Our goal is to ensure patient safety through comprehensive safety surveillance.

Why Novo Nordisk?

Novo Nordisk is a leading global healthcare company with over 100 years of experience in driving change to defeat serious chronic diseases. We are a recognized leader in diabetes care, expanding our reach globally and impacting millions of patient lives daily. We offer a dynamic and inclusive work environment that values the contributions of every employee. At Novo Nordisk, we believe in working toward something bigger than ourselves, and together, we are life-changing.

How to Apply:

To submit your application, please upload your CV and motivational letter online by clicking on Apply and following the instructions.

Application Deadline: 27 December 2024

Disclaimer:

Please be cautious of fraudulent job offers claiming to be from Novo Nordisk. Novo Nordisk does not extend unsolicited employment offers or request personal information or payment as part of the recruitment process.

Diversity and Inclusion:

At Novo Nordisk, we are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities in which we operate. We provide equal opportunities for all job applicants.

Together, we’re life-changing.

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Senior Safety Medical Writer

Job Description

About the Position

Key Responsibilities:

Qualifications:

About the Department:

Why Novo Nordisk?

How to Apply:

Disclaimer:

Diversity and Inclusion:

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