job title: Sr drug safety associate(novo nordisk)

The Position :

As a Senior Drug Safety Associate you will be responsible for the comprehensive management of both serious and non-serious adverse event reports from various sources. Your core duties will include initial medical evaluation, accurate case entry, and verification of safety data within the Novo Nordisk safety database (Argus). You will ensure consistent and precise coding using MedDRA, evaluate causality, seriousness, and listedness, and ensure that case narratives reflect accurate and relevant safety information. You will also assess the need for follow-up, issue appropriate queries in the EDC system and/or to affiliates, and actively participate in weekly literature surveillance activities.

• Responsible to conduct medical evaluation, coding, and case processing of serious and non-serious adverse events in compliance with GxP and regulatory requirements, using Argus and MedDRA.

• Liaise with global affiliates, partners, and internal stakeholders to clarify safety data, ensure timely follow-up, manage local literature, and support compliance activities.

• Collaborate with Safety Reporting and IT teams for data retrieval, custom reporting, and to assess system/process changes impacting pharmacovigilance operations.

• Ensure Support system optimization and data integrity, collaborating with Safety Reporting and IT for custom data retrieval, reporting, and assessing the impact of system or process changes on pharmacovigilance activities.

• Mentor and train colleagues, act as a buddy, and proactively contribute to continuous process improvement across global safety functions.

Qualifications:

We are looking for a candidate who can bring the following skills and experience to the role:

• Graduation and/or post-graduation in Life Sciences (e.g., Medicine, Pharmacy, Biotechnology, Nursing).

• Minimum experience of 4 years in processing of Individual case safety reports (ICSR). Experience in mentoring, training, quality trend analysis will be preferred.

• Sound knowledge and hands-on experience in Pharmacovigilance and adverse event reporting processes which includes triage/intake, data entry, Quality review within various case types. Knowledge of safety databases like Argus and familiarity with MedDRA coding.

• Strong understanding of medical terminology, clinical pharmacology, and global PV regulatory requirements. Familiarity with GxP as well as GDPR standards and compliance expectations within a pharmaceutical setting.

• Proficient in MS Windows applications, including Excel, Word, Outlook, and PowerPoint.

• Excellent written and verbal communication skills in English, with a strong ability to convey medical and scientific concepts clearly. Proven ability to work within cross-functional teams and collaborate across global departments and affiliates.

• Demonstrated ability to foresee and assess the impact of system/process changes on safety operations.

• Solid understanding of Novo Nordisk products, including mechanisms of action, safety profiles, and patient populations. Experience working in a pharmaceutical company or a similar organization.