Join Novo Nordisk as a Safety Surveillance Adviser
Safety Surveillance Adviser
Category: Regulatory Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN
Department: Global Safety Global Business Service (GS-GBS).
The Role
As a Safety Surveillance Adviser, you will be responsible for the establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate, and chair the NN cross-functional safety committee throughout the lifecycle of the actual product—present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements and recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities:
- Act as owner of the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for development products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer.
- As the author, you will prepare relevant 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) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates.
- Provide 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.
- You will provide proactive safety communication by participating in project/trial groups/teams established, as appropriate, and conduct investigator training as required.
- Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs).
Qualifications
- A Master's in Medicine/MD post-MBBS graduate is preferred.
- Relevant experience in signal management, aggregate management, and 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.
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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
November 30, 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 in 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.
https://pharmastuff.org.in/job/safety-surveillance-adviser-novo-nordisk
