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Safety Surveillance Advisor I

2+ years
Preffered by Company
10 Aug. 26, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any 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

Are you motivated by challenges and thrive in dynamic environments? Do you excel in collaborative settings and strategic alignment? If you are driven by continuous improvement and eager to make a difference, we invite you to apply for the role of Safety Surveillance Adviser at Novo Nordisk. Join our growing team in a global, international environment and contribute to life-changing work.

Position Overview

As a Safety Surveillance Adviser, you will play a key role in establishing and maintaining the safety profile of Novo Nordisk products throughout their development and post-marketing phases. You will oversee the safety surveillance process, from pre-approval to post-approval, and communicate safety issues both internally and to health authorities as needed. Your responsibilities will include chairing cross-functional safety committees, preparing safety reports, and providing critical safety input for various documents and communications.

Key Responsibilities

  • Safety Profile Management: Oversee the safety sections of the Company Core Data Sheet (CCDS) for development products and maintain labeling for marketed products. Review and provide safety input for labeling change requests (LCRs).
  • Report Preparation: Author sections of Development Safety Update Reports (DSURs), Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs). Respond to queries from health authorities and internal Novo Nordisk affiliates.
  • Safety Communication: Contribute to the Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator’s Brochure (IB), and other related documents. Participate in project/trial teams and conduct investigator training as required.
  • Stakeholder Interaction: Address inquiries from health authorities and Ethics Committees (ECs) regarding safety aspects of protocols and patient information. Manage interactions with Data Monitoring Committees (DMCs).

Qualifications

  • Education: Master’s in Medicine or MD preferred.
  • Experience: Significant experience in signal management, aggregate management, and individual case safety reports (ICSRs).
  • Skills: Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint). Fluent in written and spoken English. Strong analytical mindset and professional authority. Well-organized with a quality-oriented approach and proactive planning skills. Excellent communication abilities and a team player with cross-cultural awareness.

About the Department

Global Safety - Global Business Services (GS-GBS), established in 2010, serves as a hub for safety case processing. We handle case processing from various sources, including spontaneous reports, literature, solicited reports, and clinical trials. Our department is involved in complete case processing, medical review, safety report submissions, training, quality control, signal detection, risk mitigation, and literature surveillance.

Working at Novo Nordisk

Novo Nordisk is a global healthcare leader with a century-long legacy of combating serious chronic diseases. Expanding beyond diabetes care, we impact the lives of over 40 million patients daily and are ranked among the world’s top 20 most valuable companies. Our success depends on the talent and collaboration of our more than 63,000 employees. We value diverse perspectives and strive to be the best company for the world. At Novo Nordisk, we are working together to make a life-changing impact.

Application Process

To apply, please submit your CV and motivational letter online by clicking "Apply" and following the instructions.

Deadline: August 31, 2024

Disclaimer

Please be aware of fraudulent job offers that may appear to come from Novo Nordisk. We do not extend unsolicited employment offers or request personal information, equipment purchases, or funds as part of the recruitment process. Refer to our official recruitment guidelines for more information.

Commitment to Diversity and Inclusion

Novo Nordisk is committed to creating an inclusive culture that celebrates diversity and supports equality of opportunity. We are dedicated to building a workforce that reflects the communities we serve and the patients who rely on our products. Together, we are life-changing.

Join us at Novo Nordisk. Together, we go further. Together, we're life changing.