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

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