AstraZeneca Hiring Scientist – Clinical Trial Safety | AstraZeneca Careers
Explore an exciting opportunity at AstraZeneca Careers for the role of Scientist, Clinical Trial Safety, ideal for professionals seeking impactful clinical research jobs in a global scientific environment. This position empowers skilled life science experts to contribute to clinical data accuracy, patient safety, and innovative healthcare advancements. Join a dynamic research team at AstraZeneca and help shape the future of clinical development.
Job Details:
- Job Title: Scientist, Clinical Trial Safety
- Location: Bengaluru, Karnataka, India
- Job ID: R-240643
About The Company:
AstraZeneca is a globally recognized biopharmaceutical leader committed to advancing science and developing life-changing medicines. With a strong focus on innovation, data-driven research, and collaborative teamwork, AstraZeneca fosters an environment where scientific excellence drives global patient impact. The Trial Safety Review Center (TRISARC) plays a critical role in ensuring clinical trial safety, data accuracy, and patient well-being across research programs.
Job Description:
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, he/she 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.
Key Responsibilities Required For AstraZeneca Careers:
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/best practices, 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
Essential Skills/Experience For Clinical Research Jobs:
- Educational degree or equivalent work experience in directly related fields (preferably pharmacy)
- 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
- Team player, able to work individually
- Computer proficiency
- Excellent knowledge of spoken and written English
- Exhibit of AZ Values and Behaviours
Desirable Skills/Experience
- Pharmacovigilance background or experience working on clinical studies and/or study safety methodology
- Clinical/medical background with practical experience in reviewing SAEs and other safety events
- Understanding of the clinical study and drug development process
- Understanding of clinical data flow
- Programming experience
Key Relationships to Reach Solutions
Internal (to AZ or team):
- Internal Teams: TRISARC LT, TRISARC Scientists, peers and colleagues
- Partners from collaborating departments: Study Physicians, Clinical Scientists and their line managers, Data Management, Centralised Monitoring, Study Management, Site Management and Monitoring
External (to AZ):
- Interns
- Vendors and Suppliers
