Senior Drug Safety Associate

Senior Drug Safety Associate

Novo Nordisk Global Business Services

Senior Drug Safety Associate

Are you driven by challenges and energized by a fast-paced, dynamic environment? Do you thrive in a role where strategic alignment, stakeholder collaboration, and continuous improvement are key to success? We are looking for a Senior Drug Safety Associate to join our growing team in an international setting. In this pivotal role, you will work closely with cross-functional teams to ensure the highest standards of patient safety and regulatory compliance throughout the drug development lifecycle. Apply now and become part of a collaborative, forward-thinking environment where your expertise truly makes an impact.

About The Department:

Global Patient Safety Bangalore (GPS-BLR) was set up in 2010 as one of the hubs for safety case processing. We handle case processing and medical review of Individual Case Safety Reports from different sources (spontaneous, literature, solicited and clinical trials). We are additionally engaged in safety surveillance, safety medical writing, safety report submission, training, quality control of ICSRs, Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.

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.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

29th July 2025.

Disclaimer

It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.