Senior Safety Medical Writer

Novo Nordisk

8+ years

Not Disclosed

Bangalore

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: PhD/MD 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

Job Title: Safety Medical Writer

Department: Safety Surveillance, Global Patient Safety
Location: Bangalore, India or Søborg, Denmark
Company: Novo Nordisk

About the Department

Safety Medical Writing is a critical global team within Global Patient Safety at Novo Nordisk, dedicated to ensuring the safety of patients by conducting thorough surveillance on both marketed and developmental products worldwide. This department works collaboratively across Novo Nordisk’s global teams to support the development of safety reports and regulatory documentation that address the safety profiles of our products.

The Position

As a Safety Medical Writer at Novo Nordisk, you will be responsible for preparing complex safety-related documents, such as Aggregate Safety Reports, Risk Management Plans (RMPs), and responses to Health Authority inquiries. Your role will involve collaborating with various cross-functional teams, including Clinical Development and Regulatory Affairs, to ensure high-quality, timely, and compliant scientific writing. Additionally, you will contribute to the evaluation and implementation of changes in guidelines to maintain regulatory compliance and support process improvement initiatives within Safety Surveillance Reporting.

You will also act as a mentor and expert for junior team members, sharing insights and fostering an environment of continuous learning and improvement.

Key Responsibilities

Prepare Safety Reports: Develop Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and responses to regulatory agencies, ensuring adherence to global regulatory requirements.
Collaboration: Work with cross-functional teams (Clinical, Regulatory, etc.) to compile and report safety data.
Process Improvement: Drive process optimization and contribute to the development of medical writing competencies within Safety Surveillance.
Compliance & Knowledge: Stay updated on global safety reporting guidelines and regulations, ensuring compliance in all documentation.
Mentorship: Provide expert guidance and support to junior team members, fostering an environment of professional growth and excellence.

Qualifications

We are looking for candidates with the following qualifications:

Required:

Master’s degree and/or PhD in Life Sciences (Pharmacy, Medicine, Veterinary, Biological Sciences)
At least 8+ years of experience working in pharmacovigilance and medical writing
Extensive experience in preparing PSURs, DSURs, RMPs, and understanding the guidelines and regulations driving their preparation
Strong analytical skills with experience working with large datasets
Fluency in English (written and spoken)
Proficiency in MS Office

Preferred:

Experience in handling documents of high complexity, such as those related to Marketing Authorization Applications
Experience with regulatory submissions and specialized tasks within the pharmacovigilance space is a plus

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a rich 100-year legacy in the field of chronic disease management, particularly in diabetes care. With a focus on innovation and the impact on patient lives, Novo Nordisk is committed to improving the lives of over 40 million patients globally. We prioritize diversity, inclusion, and collaboration across our teams to reach our goals of transforming patient care worldwide.

Apply Now

To apply for this role, please submit your CV and motivational letter through the Novo Nordisk application portal by January 19, 2025.

Apply Now!

Important Notice

Be aware of fraudulent job offers that might pose as Novo Nordisk recruiters. Novo Nordisk does not charge applicants or ask for funds as part of the recruitment process. Only use the official Novo Nordisk channels for job applications.

Novo Nordisk is an equal opportunity employer. We are committed to creating a diverse and inclusive culture that celebrates different perspectives, backgrounds, and experiences. Together, we are changing lives.

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Senior Safety Medical Writer

Job Description

Job Title: Safety Medical Writer

About the Department

The Position

Key Responsibilities

Qualifications

Required:

Preferred:

About Novo Nordisk

Apply Now

Important Notice

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