Event Adjudication Professional Ii

2 weeks ago

Bengaluru Karnataka, India Novo Nordisk Full time

Event Adjudication Professional II

**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety, GBS.-
**The Position**
- As an Event Adjudication Professional II, you will act as project manager and drive planning, execution, and finalization of Event Adjudication (EA) activities on clinical trials. You will be the contract owner of the EA Supplier service in collaboration with Clinical Outsourcing Management (COM) and other relevant stakeholders according to NN SOPs and the EA Contract Owner Guidance Document. Major responsibilities include:
- Contribute to external supplier selection in collaboration with Clinical Outsourcing management to ensure effective support of NN EA process including IT requirements in Safety Operations.
- Ensure event oversight, clear communication, and report EA status to relevant stakeholders. As project manager ensure supplier prepared documents are reviewed and finalised according to timelines, NN SOPs & procedures and the contract.
- Support review of internal documents and systems according to timelines, NN SOPs & procedures to ensure that all relevant adjudication information is captured and in line / compatible with the EA process.
- Drive the set-up of internal systems to support event adjudication and perform event processing of adverse events relevant for adjudication according to agreed workflow.
- Ensure that the event pipeline is well controlled by following supplier status and action at each relevant stage as well as participating in status meetings and perform oversight of supplier performance to ensure work is performed in accordance with agreed process documents, workflows and GCP.
- Provide training to monitors and investigators in handling of adjudication data in clinical trials (e.g. at Investigator and Monitor meetings) and ensure Audit and Inspection readiness.
- Contribute to and keep event adjudication procedures in compliance with all existing applicable requirements.
- Support sharing better practice and consistency within EA.**Qualifications**
- MSc/M. Pharm or Master’s degree in health sciences or Bachelor’s degree in health sciences or equivalent graduation.
- Minimum 5 years of work experience in Pharma Industry, with 2-3 years of experience in clinical adjudication or clinical project management.
- Knowledge of event adjudication, clinical development, clinical trial methodology and GCP requirements.
- Knowledge of the FDA and EMEA guidelines related to adjudication and relevant endpoints.
- Knowledge of diseases, their clinical manifestations, treatment and complications.
- Often requires the ability to handle complex tasks with few or no defined procedures in place.
- Experienced user of the Microsoft package specifically Excel.
- Knowledge of clinical data collection methods, e.g. EDC.
- Understanding of Clinical data landscape.
- Fluent in English, both written and spoken.
- Team oriented personality with high degree of flexibility and cross-cultural awareness.
- Good communication, presentation, and negotiation skills.
- Ability and willingness to adjust quickly to new situations in a continuously developing environment.**About the Department**
- The Event Adjudication area is one of the functional areas in Global Safety which consists of ~30 highly engaged team members from various academic backgrounds. We establish and execute procedures for setting up, conducting, and closing event adjudication activities in clinical trials. We work in a fast-paced environment on an increasing number of trials in the late-stage clinical development, where adverse events require adjudication. Event adjudication is a process where an independent review board of medical specialists assesses relevant adverse events for fulfilment of pre-defined clinical criteria, with the purpose of generating high quality data for our clinical trials. This position is based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different clinical projects and engaging with multiple stakeholders at the global level.**Working At Novo Nordisk**
- At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales
- we're all working to move the needle on patient care.**Contact**Deadline**- 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

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