Novo Nordisk Hiring Safety Surveillance Adviser Bangalore

Join Novo Nordisk as a Safety Surveillance Adviser

Safety Surveillance Adviser I

Category: Regulatory Affairs & Safety Pharmacovigilance

Location: Bangalore, Karnataka, IN

Department: Global Safety Global Business Service (GS-GBS). Do you find your inspiration stemming from confronting challenges within a dynamically shifting environment? Flourish in an atmosphere where close collaboration with pivotal stakeholders and strategic synchronization stands as paramount? Possess an unwavering can-do attitude with an insatiable hunger for continuous enhancement as an inherent facet of your professional pursuits? If so, the opportunity we present may align seamlessly with your aspirations. Waste no time, seize the chance, and become an integral part of our burgeoning team, thriving within an expansive international framework. The Role Embark on the role of a Safety Surveillance Adviser, entrusted with the monumental task of sculpting the safety profile of products during their developmental phases and ensuring the perpetual upkeep of labeling for products already circulating in the market. Dive into the realm of ongoing, meticulous surveillance of Novo Nordisk (NN) products, both before and after approval, leveraging safety data procured from a myriad of global sources. Your duty extends to the seamless communication of drug safety concerns internally as well as to health authorities (HAs), as necessitated. Chair the NN cross-functional safety committee, orchestrating its operations throughout the product's lifecycle, and present comprehensive analyses and findings of ongoing safety surveillance at predetermined intervals to guide the committee's endorsements and recommendations. Assume responsibility for all facets concerning patient safety within clinical trials. Your roster of responsibilities includes:

• Serving as the custodian of safety sections within the evolving Company Core Data Sheet (CCDS) for developmental products.
• Maintaining labeling for marketed products and participating as a reviewer for labeling change requests (LCRs), offering valuable safety insights in the process.
• Crafting pertinent sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs), in alignment with implementation plans or as mandated by Health Authorities (HAs). Responding promptly to requests from HAs and internal queries from NN affiliates.
• Providing safety input to the Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator’s Brochure (IB), integrated safety summaries, abstracts, and planned publications.
• Spearheading proactive safety communication through participation in pertinent project/trial groups/teams and facilitating Investigator training when deemed necessary.
• Furnishing responses to inquiries from HAs and Ethics Committees (ECs) concerning safety aspects of protocols and Patient Information (PI)/Informed Consent (ICs), ensuring seamless deliverables to/from Data Monitoring Committees (DMCs).

Qualifications

• Master's in Medicine/MD post MBBS graduate is preferred.
• Relevant experience in Signal Management, Aggregate Management, ICSR.
• Proficiency in the Microsoft Office package (Outlook, Word, Excel, and PowerPoint).
• Fluent command over written and spoken English.
• Possession of an analytical mindset.
• Professional authority coupled with a quality-oriented approach, organizational prowess, and an unwavering commitment to excellence.
• Proactive planning capabilities to meet predefined deliverables.
• Strong communication skills, both verbal and written.
• Innate curiosity and a perpetual quest for improvement opportunities.
• A team player exhibiting a high degree of flexibility and a service-oriented disposition.
• Cross-cultural awareness and an inherent ability to swiftly adapt to the ever-evolving landscape.

[caption id="attachment_65522" align="aligncenter" width="1200"] Novo Nordisk Hiring Safety Surveillance Adviser Bangalore[/caption] About the Department Established in 2010, Global Safety Global Business Service (GS-GBS) stands as a pivotal hub for safety case processing. At GS-GBS, we meticulously handle case processing from diverse sources including spontaneous, literature, solicited, and clinical trials. Our purview extends beyond mere case processing and medical review to encompass safety report submission, training, Learn It administration, quality control of Individual Case Safety Reports (ICSR), Argus configuration and maintenance, information technology quality assurance, signal detection activities, risk mitigation activities, training coordination, and literature surveillance activities, inclusive of medical literature monitoring. Working at Novo Nordisk We take immense pride in being a life-science company, with life serving as our raison d'être. Inspired by life in all its myriad forms - its ebbs and flows, its opportunities, and its challenges - life, for employees at Novo Nordisk, encompasses a myriad of meanings. From the fundamental building blocks of life that underpin groundbreaking scientific research to our rich personal lives that fuel and invigorate our professional endeavors, life, in essence, forms the bedrock of our existence. Ultimately, our collective purpose revolves around ensuring that individuals can lead lives unencumbered by the shackles of chronic diseases. Contact To kick-start your journey, kindly submit your application by uploading your CV and motivational letter online (click on Apply and follow the instructions). Deadline March 31st, 2024. We remain steadfast in our commitment to fostering an inclusive recruitment process and championing equality of opportunity for all our job applicants. At Novo Nordisk, we recognize that mere aspiration to be the best company in the world falls short of the mark. Our vision extends beyond mere excellence to encompass a steadfast commitment to becoming the best company for the world. We firmly believe that this lofty aspiration can only be realized through the collective efforts of talented employees boasting diverse perspectives, backgrounds, and cultures. Thus, we are resolutely committed to fostering an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, we're poised to effect life-changing transformations.

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