Safety Surveillance Adviser I

2 weeks ago


Bengaluru Karnataka, India Novo Nordisk Full time

Safety Surveillance Adviser I

**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department** : Global Safety Global Business Service (GS-GBS).-
**The Position**
- As a Safety Surveillance Adviser, you will be responsible for 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/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 developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer.
- As 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 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 participation 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**
- Masters in Medicine/MD post MBBS graduate is Preferred.
- Relevant Experience in Signal Management, Aggregate Management, ICSR.
- Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint)_._
- Fluent in written and spoken English.
- Analytical mind-set.
- Professional authority.
- Quality mind-set, well-organised and strive for excellence.
- Pro-active planner to meet agreed deliverables.
- Strong communicator (verbally and in writing).
- Curious and constantly looking for improvement opportunities.
- Team player with high degree of flexibility and service mindedness.
- Cross-cultural awareness.
- Ability and willingness to quickly adjust to changes in a continuously developing environment.

**About the department**
- Global Safety Global Business Service (GS-GBS) was set up in 2010 as one of the hub for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited and clinical trials. Apart from complete case processing and medical review, GS-GBS is also engaged in 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 co-ordination and literature surveillance activities, including medical literature monitoring.**Working at Novo Nordisk**
- We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.**Contact**Deadline**
- 5th February, 2024.- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’



  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Safety Surveillance Advisor I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department** : Global Safety - Global Business Services (GS-GBS).- **The Position** - As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the...


  • Bengaluru, India Novo Nordisk Full time

    **The Position** As a Safety Surveillance Adviser, you will be responsible for 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...


  • Bengaluru, India Novo Nordisk Full time

    **Department**: Global Safety. **About the Department** Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for global handling and reporting of adverse events reports. **The Position** All tasks in the GS-GBS SO Safety Operations Advisers...

  • Safety Officer

    2 weeks ago


    Bengaluru, Karnataka, India buildAhome Full time

    Supporting the development of OHS policies and programs - Advising and instructing on various safety-related topics (noise levels, use of machinery etc.) - Conducting risk assessment and enforcing preventative measures* Identifying hazards, ensuring compliance with legislation, and promoting a culture of health and safety in the workplace. - Identifying...


  • Bengaluru, India Teznel Technologies Pvt. Ltd. Full time

    **Job title **Trust Safety Manager - TSM **No. of Positions **3 **Location **Marathalli, Bangalore **Eligibility **Degree **Job title **Trust Safety Officer - TSO **No. of Positions **30 **Location **Marathalli, Bangalore **Eligibility **Degree **Requirement** 1. Graduate 2. Good English Communication Skill 3. Certificate - Fire Training, Baggage...


  • Bengaluru, India Novo Nordisk Full time

    **Department - GS GBS Safety Medical Writing** **The Position** As a Safety Medical Writer (SMW), you will plan, drive and co-ordinate preparation of safety documents to ensure submission according to agreed timelines. You will prepare aggregate safety reports, clinical risk management plans and responses to questions from health authorities in...

  • Safety Officer

    Found in: Talent IN C2 - 2 weeks ago


    Bengaluru, India GANGA ACROWOOLS LIMITED Full time

    Safety Officer duties and responsibilities Plan and implement OHS policies and programsAdvise and lead employees on various safety-related topicsPrepare educational seminars and webinars on a regular basisReview existing policies and proceduresAdhere to all the rules and regulationsWork with HR to set up a new employee on-boarding process for safetyConduct...

  • Post Market Surveillance Quality Engineer

    Found in: beBee S IN - 3 weeks ago


    Bengaluru, India Intuitive Surgical Full time

    Job DescriptionPrimary Function of the PositionThe Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues, and support the execution of robust resolutions. Functions collaborating with the Post...

  • Post Market Surveillance Quality Engineer

    Found in: beBee S IN - 2 weeks ago


    Bengaluru, India Intuitive Surgical Full time

    Job DescriptionPrimary Function of the PositionThe Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues, and support the execution of robust resolutions. Functions collaborating with the Post...

  • Post Market Surveillance Quality Engineer

    Found in: beBee jobs IN - 2 weeks ago


    Bengaluru, Karnataka, India Intuitive Surgical Full time

    Job DescriptionPrimary Function of the PositionThe Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues, and support the execution of robust resolutions. Functions collaborating with the Post...


  • Electronic City, Bengaluru, Karnataka, India Infinite solution Full time

    Plan and implement OHS policies and programs - Advise and lead employees on various safety-related topics - Adhere to all the rules and regulations - Will have sound knowledge in Site Safety rules in Construction sector. - Will have knowledge in Work permit like Height, Cold work, Hot work - Working knowledge in power plant will be preferred. - Prepare and...

  • Executive/Sr. Executive

    Found in: Talent IN C2 - 2 weeks ago


    Bengaluru, India Schindler Full time

    ID:  73067 We Elevate… You Schindler grundades 1874 i Schweiz och är en ledande leverantör av hållbar och effektiv mobilitet i städer. Schindlers hissar, rulltrappor och rullband transporterar 2 miljarder människor varje dag. Tillsammans med våra kunder möjliggör vi framkomlighet av människor och varor genom att sammankoppla...

  • Post Market Surveillance Data Science Expert

    Found in: Talent IN C2 - 2 weeks ago


    Bengaluru, India Philips Full time

    Job TitlePost Market Surveillance Data Science ExpertJob DescriptionJob title: Post Market Surveillance Data Science Expert Job Summary:We are seeking an experienced and highly skilled Senior Data Science Expert with a proven track record of at least 10+ years in the field. The ideal candidate will be responsible for leading and executing complex data...

  • Pilot - I

    2 days ago


    Bengaluru, Karnataka, India ideaForge Full time

    Mobility Solutions Bengaluru (Hybrid) Associate **Job Description**: As a Drone Pilot at ideaForge, you will be responsible for safely and effectively operating our drones for various missions including aerial surveys, inspections, and data collection. You will play a crucial role in ensuring the success of our projects by executing precise and...


  • JP Nagar, Bengaluru, Karnataka, India 3G HR SERVICES Full time

    **Greetings From 3G HR SERVICES!!!** We are hiring for **Customer Service Advisor** Position**:Customer Service Advisor** Note: I**nbound/Outbound (Blended) depending upon the client requirement.** **Roles and Responsibilities**: - 6 day working (Rotational week-off) - Responsible for upselling on Feedback calls and renewal-related services -...


  • Bengaluru, India I Mates Consultants Full time

    Share- Tweet **Posted By**:I Mates Consultants | **Posted on**: April 04, 2023**: - India Bengaluru/Bangalore - 800000-1100000 RS - 3-10 **Scope of the Role**: SBL RM s will be placed in Digital branches ( Where there will not be any manual functions inside which will be purely digitally driven branch ) SBL need to support the clients incase if any manual...

  • Advisor/Senior Advisor-Medical Review

    Found in: Talent IN C2 - 2 days ago


    Bengaluru, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Key Responsibilities for Global Patient Safety (GPS) Medical Review 1.Medical support of individual case adverse event and product complaint reporting process Provide the medical and clinical expertise necessary to support case managers and call center...

  • Commis I

    2 weeks ago


    Bengaluru, Karnataka, India Brik Oven Full time

    Responsibilities include: - Assists and supports the chef de partie in the preparation of different foods - The commis chef must also perform many basic tasks of food preparation and organization in the kitchen. - The commis chef must maintain high standards of health and safety, including personal hygiene. - Assists in all kitchen related activities...

  • Commis I

    1 day ago


    Bengaluru, Karnataka, India Brik Oven Full time

    Responsibilities include: - Assists and supports the chef de partie in the preparation of different foods - The commis chef must also perform many basic tasks of food preparation and organization in the kitchen. - The commis chef must maintain high standards of health and safety, including personal hygiene. - Assists in all kitchen related activities...

  • Risk Investigator

    12 hours ago


    Bengaluru, Karnataka, India PhonePe Full time

    **About PhonePe Group**: PhonePe is India’s leading digital payments company with 50 crore (500 Million) registered users and 3.7 crore (37 Million) merchants covering over 99% of the postal codes across India. On the back of its leadership in digital payments, PhonePe has expanded into financial services (Insurance, Mutual Funds, Stock Broking, and...