JOB DESCRIPTION

Key Responsibilities:
• Handling of non-serious and serious adverse events.

Main Job Tasks:

Handling of Non-serious and Serious adverse events:

• Perform initial evaluation of reported adverse events (serious and non-serious) from all sources.
• Perform case entry and verification of reported non-serious and serious adverse events; enter the reported
information in the Novo Nordisk safety database – Argus, based on individual case histories, correspondence
with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
• Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus
with the use of MedDRA (Medical Dictionary for Regulatory Activities).
• Evaluate causality, seriousness and listedness for all cases.
• Ensure that case narrative comprises correct and appropriate safety information.
• Assess the need for follow up information and issue follow up requests for all cases and post queries in EDC
and/or to affiliate
• Perform weekly literature surveillance related activities.
• Ability to work within strict timelines.

In addition:

• Ensure that all tasks are performed in compliance in accordance to GXP requirements.
• Maintain a network of safety contacts within Global Safety (GS) and affiliates.
• Communicating with the SO-DK and affiliates to query and/or clarify the details related to the safety data.
• Liaise with affiliates and partners for local literature and compliance.
• Liaise with Safety Reporting and IT in all aspects of data retrieval and custom reporting.
• Participate in inspections and audits when required.
• Assist with related administrative and procedural activities as required or requested.
• Independent decisions making regarding evaluating the submission of adverse event reports.
• Ensure compliance with the training plan provided for the role.
• Contribute to process improvements.
• Act as a buddy for colleagues.

Scope of Authority:
• NA
Other Areas of Responsibility:

• NA
Communication and Stakeholder Interaction:

Key stakeholders Type of communication

Internal Stakeholders • Expected to have a customer-oriented view.

• Global Safety • Understand and respect GS stakeholder’s expectations
• Novo Nordisk Affiliates and concerns.
• Customer Complaint Centre • Handle customer inquiries effectively, professionally and
• Global Development on time.
• Proactively contribute to solving GS stakeholder’s needs.
• Build and maintain good relations with GS stakeholders

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 External Stakeholders
• For trials utilising Electronic Data
Capture (EDC) there will be direct
correspondence with trial investigators
• Regulatory Authorities
• The communication to the investigators should be:
▪ Respectful
▪ Not leading
▪ Unambiguous
• Timely reporting and communication of adverse event
reports in compliance with world-wide regulations have
a significant impact on the existence of a pharmaceutical
company.
• Timely submission of AE reports has high influence in the
department as well as Novo Nordisk

Innovation and Change:

• General procedures are available; however, many cases are complex and demand flexibility and initiative. An
ability to independently carry through the tasks in order of priority is of prime importance.
• Compliance with drug safety in an environment with complicated and frequently changing regulatory
requirements and guidelines is an essential part of the job.
Geographic Responsibility:

• NA
Knowledge, Skills and Experience:

Education: Graduation and/or post-graduation in life sciences

Experience: • Basic knowledge of Pharmacovigilance is expected

• Basic Knowledge of medical terminologies and clinical pharmacology.
• Basic understanding of the internal and external Pharmacovigilance setting and
requirements.
• Basic working knowledge of MS Windows applications including MS Office tools
• Good communication skills (written and oral), with English correspondence
• Basic Novo Nordisk organizational or pharmaceutical company understanding.
• Basic knowledge of Novo Nordisk products, incl. mechanism of action, safety
profile, patient population, etc.
• Basic knowledge of GXP requirements.
• Basic knowledge of Pharmacovigilance principles and international regulatory
requirements regarding drug safety.

Personal skills: • Self-motivated and proactive.

• Quick learning and analytical skills.
• Ability to take up initiatives.
• Team oriented personality with high degree of flexibility.
• Ability to capture attention and motivate a team around discussion.
• Ability to work independently and within strict timelines.
• Attention to detail and quality.
• Willingness to occasionally work at unusual times.
• Strive for continuous improvement

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