Senior Safety Medical Writer

8+ years

Not Disclosed

Bangalore

10 Jan. 6, 2025

Job Description

Job Type: Full Time Education: MD/PhD/PharmD/MSc 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

Senior Safety Medical Writer
Category: Clinical Development
Location: Bangalore, Karnataka, IN

Department: Safety Surveillance, Global Patient Safety

About the Role

Are you passionate about ensuring patient safety through precise and impactful scientific writing? Do you excel at managing complex safety surveillance reports? Novo Nordisk is seeking experienced Senior Safety Medical Writers to join our team and lead high-complexity safety reporting tasks. If you’re ready for a transformative career, apply today!

Key Responsibilities

As a Senior Safety Medical Writer, you will:

Prepare complex aggregate safety reports, such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), 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 documentation and timely reporting.
Monitor, evaluate, and implement changes to local and global guidelines to maintain compliance.
Lead process improvement initiatives and foster competency development within the Safety Surveillance Reporting team.
Act as a subject matter expert, mentoring junior team members and proactively enhancing your contributions to the department.

Qualifications

To be successful in this role, you’ll need:

A Master’s or Ph.D. in Life Sciences (Pharmacy, Medicine, Veterinary, or Biological Sciences).
8+ years of experience in pharmacovigilance and medical writing, with strong analytical skills and experience handling large datasets.
Expertise in preparing PSURs, DSURs, RMPs, and an in-depth understanding of relevant guidelines and regulations.
Fluency in written and spoken English, with advanced proficiency in MS Office.
Experience handling complex documentation (e.g., Marketing Authorization Applications) or performing specialist tasks is an advantage.

About the Department

The Safety Medical Writing team is part of Global Patient Safety, a 400+ member global organization dedicated to ensuring the safety of Novo Nordisk’s marketed and developmental products. With teams in Bangalore, India and Søborg, Denmark, we provide robust safety surveillance reporting to ensure patient safety worldwide.

About Novo Nordisk

Novo Nordisk is a global leader in healthcare, with a 100-year legacy of fighting serious chronic diseases. Our work impacts over 40 million patients daily, powered by the collaboration of 63,000+ employees worldwide. Together, we aim to create lasting change for a healthier world.

Join Novo Nordisk for a career that’s more than just a job—it’s life-changing.

Application Process

Submit your CV and motivational letter online by clicking "Apply Now."
Deadline: 19 January 2025

Important Note:
Novo Nordisk does not solicit personal information, equipment purchases, or funds as part of the recruitment process. Be wary of fraudulent job offers impersonating Novo Nordisk recruiters.

Diversity & Inclusion

At Novo Nordisk, we believe in building a workplace that reflects the diversity of the world we serve. We’re committed to creating an inclusive culture where all perspectives, backgrounds, and talents are celebrated. Together, we’re making life-changing progress for patients and communities worldwide.

Join us! Together, we’re life-changing.

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Senior Safety Medical Writer

Job Description

About the Role

Key Responsibilities

Qualifications

About the Department

About Novo Nordisk

Application Process

Diversity & Inclusion

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