Senior Safety Medical Writer

0-2 years

Not Disclosed

Bangalore

10 Jan. 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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
Location: Bangalore, India
Job Category: Clinical Development

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About the Position:

Are you passionate about patient safety and skilled in scientific writing? Novo Nordisk is seeking Safety Medical Writers to join our Safety Surveillance, Global Patient Safety team. In this role, you will manage high-complexity safety reporting tasks, including the preparation of aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority queries. If you are looking for a challenging and rewarding career that directly impacts patient safety, this could be the opportunity for you.

Key Responsibilities:

Prepare complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority inquiries.
Collaborate with cross-functional teams, including Clinical Development and Regulatory Affairs, to ensure high-quality scientific writing and timely safety data reporting.
Contribute to the evaluation and implementation of changes in global/local guidelines to ensure compliance with both internal and external standards.
Drive process improvements, medical writing competency development, and skill building within Safety Surveillance Reporting.
Mentor junior team members, sharing knowledge and fostering an environment of excellence.

Qualifications:

Master’s degree or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological Sciences).
At least 8+ years of experience in pharmacovigilance and medical writing.
Strong analytical skills and experience working with large datasets.
Deep understanding of pharmacovigilance, drug development, and relevant safety reporting guidelines.
Expertise in preparing Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
Fluency in both written and spoken English (business language).
Advanced proficiency with MS Office.
Experience with high-complexity documents (e.g., Marketing Authorisation Applications) is a plus.

About the Department:

The Safety Medical Writing team is part of Global Patient Safety, located in Bangalore, India, and Søborg, Denmark. The team is responsible for reporting on the safety profile of all Novo Nordisk’s products, ensuring patient safety through proactive surveillance and high-quality reporting of emerging safety data.

Working at Novo Nordisk:

Novo Nordisk is a global healthcare leader with over 100 years of history in combating serious chronic diseases. We are growing rapidly and impacting millions of lives daily. With over 63,000 employees worldwide, we pride ourselves on creating an inclusive and diverse environment. At Novo Nordisk, we work together for something bigger than ourselves. Join us—Together, we go further. Together, we’re life-changing.

Application Deadline:

Submit your application by 19th January 2025 using our online application tool.

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Senior Safety Medical Writer

Job Description

Apply Now

About the Position:

Key Responsibilities:

Qualifications:

About the Department:

Working at Novo Nordisk:

Application Deadline:

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