Senior Safety Medical Writer

2+ years

Not Disclosed

Bangalore

10 Dec. 18, 2024

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
Department: Safety Surveillance, Global Patient Safety

About Novo Nordisk:

Novo Nordisk is a global healthcare leader with a rich legacy of transforming the lives of individuals with chronic diseases. We are committed to expanding our impact, reaching millions of patients daily, and changing the future of healthcare. With over 63,000 employees worldwide, our success stems from the unique skills and collaboration of our team members. Together, we strive for a common goal—to ensure a life-changing impact.

The Position:

We are seeking an experienced Safety Medical Writer to join our dynamic team. In this role, you will be responsible for preparing complex safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs). You will also respond to Health Authority questions and collaborate across various teams, including Clinical Development and Regulatory Affairs, to ensure accurate and high-quality safety reporting.

Key responsibilities include:

Safety Reporting: Prepare complex safety documents, including PSURs, DSURs, and RMPs, ensuring compliance with internal and external regulatory guidelines.
Cross-functional Collaboration: Work with Clinical Development and Regulatory Affairs teams to ensure the timely reporting of safety data.
Process Improvement: Lead initiatives to enhance medical writing competencies and improve safety surveillance processes.
Expert Guidance: Act as a mentor for junior team members, sharing expertise and proactively driving excellence in medical writing.

Qualifications:

Education: Master's degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological Sciences).
Experience: At least 8+ years of experience in pharmacovigilance and medical writing, with a solid understanding of safety reporting, including PSURs, DSURs, and RMPs.
Skills:
- Strong analytical skills with experience working with large datasets.
- Expert knowledge of pharmacovigilance processes and drug development.
- Experience handling high-complexity documents, such as submissions for Marketing Authorisation Applications.
- Proficient in MS Office and fluent in written and spoken English.

About the Department:

Safety Medical Writing is a global team within Global Patient Safety. Based in Bangalore, India, and Søborg, Denmark, this team is responsible for ensuring the safety of Novo Nordisk products by reporting emerging safety profiles and overseeing the routine surveillance of marketed and developmental products worldwide.

Working at Novo Nordisk:

Novo Nordisk is more than just a company—it’s a life-changing mission. As one of the top global healthcare companies, we empower employees to work towards improving the lives of millions. Together, we make a difference. Join us and be part of a journey that is changing healthcare for good.

Application Process:

To apply, please upload your CV and motivational letter through the application portal.

Deadline: December 27, 2024

Novo Nordisk is committed to an inclusive recruitment process and provides equal opportunities to all applicants.

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Senior Safety Medical Writer

Job Description

About Novo Nordisk:

The Position:

Qualifications:

About the Department:

Working at Novo Nordisk:

Application Process:

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