Job Title: Associate Director, Patient Safety Scientist
Location: Bengaluru, Karnataka, India
Job ID: R-239527
Date Posted: 13 Nov 2025
Global Career Level: E1
🔹 Introduction to the Role
The Associate Director, Patient Safety Scientist works closely with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to evaluate safety data, identify potential safety issues, and contribute to regulatory and safety documentation. This role involves leading discussions, presenting safety analyses, and supporting risk management activities across the product lifecycle.
🔹 Key Accountabilities
1. Pharmacovigilance & Risk Management
Lead proactive PV and risk-management planning for assigned products.
Prepare safety components of Global Risk Management Plans (GRMPs).
Evaluate safety data from pre-clinical studies, clinical trials, literature, and other sources.
Manage risk to patients and establish the product safety profile.
2. Cross-Functional Collaboration
Represent Patient Safety in cross-functional project teams for marketed and developmental products.
Collaborate with GSP and Clinical teams to author and maintain Reference Safety Information (RSI).
Contribute to safety sections of regulatory submissions (NDA/BLA, MAA).
3. Safety Data Evaluation & Documentation
Present safety issues to the Safety Information Review Committee (SIRC).
Lead data evaluations, engage with SIRC Chair, GSP, and key stakeholders.
Produce clear and accurate evaluation documents for internal and regulatory requests.
Provide strategic input and oversight for safety regulatory documents, including:
PBRERs
PSURs
DSURs
4. Leadership & Team Development
Perform duties as the Safety Strategy and Management Team (SSaMT) leader.
Train and mentor junior Patient Safety team members.
Contribute to safety components in third-party agreements and contracts.
5. External Representation
Present safety information in external meetings and scientific exchanges.
🔹 Essential Skills & Experience
Qualifications
Degree in Biosciences or equivalent healthcare/pharmaceutical discipline.
Proven competency in patient safety or clinical development.
Experience
9–11 years of direct Patient Safety experience.
12–14 years total industry experience.
Knowledge Requirements
Comprehensive understanding of Patient Safety regulatory obligations.
Awareness of PV policies, processes, procedures, and medico-legal aspects.
Communication & Interpersonal Skills
Strong interpersonal and networking capabilities.
Cultural sensitivity and ability to work across global teams.
🔹 Impact on Business Results
Ensures timely and high-quality surveillance and case-handling activities.
Supports compliance with global regulatory reporting timelines.
Contributes to correct product labeling via safety surveillance.
Maintains efficient processes with a focus on productivity and delivery.
🔹 Key Stakeholders
Patient Safety teams (all levels)
Regulatory Affairs
Cross-functional teams within AstraZeneca
🔹 Leadership Behaviours
Passion for Customers
Actively engages with internal and external stakeholders to craft complete solutions.
Thinks Strategically
Challenges existing approaches; applies broad scientific and safety perspectives.
Acts Decisively
Makes timely decisions even under uncertainty; seeks support where required.
Drives Performance
Sets clear expectations and timelines; ensures delivery of high-quality outputs.
Works Collaboratively
Incorporates diverse cross-functional insights into safety decisions.
Develops People & Organisation
Coaches junior teammates while pursuing self-development.
🔹 Working Model
Minimum 3 days per week in-office (flexible hybrid model).
Encourages collaboration, innovation, and cross-functional connection.
🔹 About AstraZeneca (Oncology Division)
Join an ambitious oncology team working to eliminate cancer as a cause of death.
AstraZeneca blends cutting-edge science with innovative technology, supported by strong investment and a bold vision. By 2025, AZ aims to deliver six new molecular entities, driven by courage, curiosity, and patient-centric decisions.
You will be part of a collaborative scientific community dedicated to accelerating breakthroughs in challenging cancer types and improving patient outcomes worldwide.
🔹 Application Details
Date Posted: 14 Nov 2025
Closing Date: 23 Nov 2025
AstraZeneca is committed to diversity, equality, and inclusive hiring practices following all global employment regulations.
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