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Scientist, Clinical Trial Safety

4 months ago

Bengaluru, India AstraZeneca Full time

**JOB TITLE : Scientist I, Clinical Trial Safety**:
**CAREER LEVEL: C**

**Leverage technology to impact patients and ultimately save lives**:
**About astrazeneca**:
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

**About our it team**:
It’s a dynamic and results-oriented environment to work in - but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross
- functionally and broadly together.

**About the role**:
The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. The primary remit of the TRISARC is to review large amounts of clinical (mainly safety) data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing study physicians and/or clinical(project) scientists to interpret medical/safety data efficiently.

The Scientist, **Clinical Trial Safety **will work closely with the Senior Scientists, Senior Analysts and Associate Director, Scientists Clinical Trial Safety to support them in reviewing important and pre-specified medical (mainly safety) data in clinical trials as operated under the Research and Development (R&D) division of AstraZeneca. During the recruitment and maintenance phases of the clinical trial, they uses the Center’s data review tools to support review and query important clinical/safety data within the scope agreed with medical team and documented accordingly. The Scientist also supports preparation/facilitation of the meetings and management of study documents and trackers relevant to TRISARC activities.

**Typical Accountabilities**:
Supporting Senior Scientist, Senior Analyst and Associate Director, Scientist in their activities:

- during study start-up activities by generating/managing the documents according to applicable procedures/standard methodologies, set up/configuration of applicable tools,
- review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure
- schedule and facilitate different types of meetings
- creating visualizations from applicable tools and prepare slides/reports/data as required
- perform quality check of documents and file TRISARC documents in eTMF

**Other activities**:

- Take on tasks as assigned by the PTS/TRISARC LT
- Provide input into non-drug project work including continuous improvement and development of procedures as needed
- Update study statuses in tracker with studies per Therapeutic area upon request
- Ensure TRISARC platforms (e.g. SharePoint) contains up-to-date information, documents, files. Coordinate updates, if needed
- TRISARC mailboxes oversight
- support preparation/participate in different type of study meetings (e.g. SSPR meetings)
- Update/keep up to date TRISARC distribution lists on ongoing basis

**Education, Qualifications, Skills and Experience**:
**Essential**
- Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields (preferably medicine, pharmacy, veterinary, biotechnology, nurse, dentist)
- Knowledge of ICH/GCP Guidelines
- Knowledge of SAE reporting requirements
- Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
- Ability to multi-task in a high-volume environment with shifting priorities
- Excellent time management
- Standout colleague, able to work individually
- Computer proficiency
- Excellent knowledge of spoken and written English
- Exhibit of AZ Values and Behaviours

**Desirable**:

- Pharmacovigilance background, or experience working on clinical studies and/or study safety methodology
- Clinical/medical background and practical experience providing a stable good knowledge in base for reviewing SAEs and other safety events
- Understanding of the clinical study and drug development process in relation to study delivery operational activities
- Understanding of clinical data flow
- Programming experience

**WHY JOIN US ?**

We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we