Associate Director, Patient Safety Scientist
Location: Bengaluru, Karnataka, India
Job ID: R-239527
Global Career Level: E1
Date Posted: 13-Nov-2025
Closing Date: 23-Nov-2025
Company: AstraZeneca
1. Role Introduction
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 risks, and contribute to regulatory safety documentation.
This role includes leading safety discussions, presenting data, and providing strategic pharmacovigilance insights throughout the product lifecycle.
2. Key Accountabilities
A. Pharmacovigilance Leadership
Lead proactive safety and risk management planning for assigned products.
Prepare safety components of Global Risk Management Plans (RMPs) with GSP and cross-functional experts.
Represent Patient Safety in cross-functional teams for marketed and developmental compounds.
Act as a Safety Strategy and Management Team (SSaMT) leader.
B. Safety Data Analysis & Evaluation
Present safety issues to the Safety Information Review Committee (SIRC) and lead data interpretation discussions.
Evaluate clinical and non-clinical safety data from:
Preclinical studies
Clinical trials
Scientific literature
External databases
Establish safety profiles and guide risk mitigation strategies.
C. Documentation & Reporting
Author high-quality, fit-for-purpose safety evaluation documents for regulatory or internal requests.
Collaborate with GSP and Clinical teams to write Reference Safety Information (RSI) for development and marketed products.
Provide strategic input for regulatory submissions:
PBRER / PSUR
DSUR
NDA/BLA
MAA
Contribute to safety sections of contracts and third-party agreements.
D. Regulatory Submissions & Compliance
Provide expertise for major regulatory submissions involving safety content.
Ensure alignment with global patient safety processes, policies, and medico-legal requirements.
Drive compliant and timely delivery of periodic safety reports.
E. Stakeholder Management & Collaboration
Network globally across multiple functions including:
Patient Safety
Regulatory Affairs
Clinical teams
Other AstraZeneca experts
Engage customers and cross-functional teams to deliver complete safety solutions.
Present safety information at external scientific meetings.
F. Training & Team Development
Mentor and train junior team members on patient safety principles, systems, and tools.
Support ongoing capability-building within the Patient Safety function.
3. Essential Skills & Experience
Education
Bachelor’s degree in biosciences, healthcare, pharmacy, or related field (or equivalent industry experience).
Professional Experience
9–11 years of patient safety experience.
Total 12–14 years of overall pharmaceutical/clinical development experience.
Strong understanding of:
Patient Safety regulations
PV processes & compliance
Medico-legal considerations in safety
Ability to interpret complex safety data from diverse sources.
Technical Skills
Solid awareness of:
Patient safety systems
Regulatory safety requirements
Risk management frameworks
Strong experience with safety surveillance and case processing.
4. Communication & Collaboration Skills
Excellent interpersonal skills and cultural awareness.
Strong global networking ability.
Capability to present complex safety data to external and internal stakeholders.
5. Impact on Business Results
Ensures timely and accurate safety reporting to regulators.
Enhances product safety profiles via ongoing surveillance.
Contributes to label updates and safety due diligence.
Improves process efficiency and productivity in Patient Safety operations.
6. Internal & External Interactions
Internal
All levels of Patient Safety
Regulatory Affairs
Clinical development teams
Cross-functional AstraZeneca departments
External
Scientific and medical experts
Regulatory authorities
Third-party partners
7. Leadership Competencies
Passion for Customers: Delivers complete, customer-oriented solutions.
Thinks Strategically: Challenges current approaches using broad scientific perspective.
Acts Decisively: Makes informed decisions under uncertainty.
Drives Performance: Ensures high-quality deliverables with clear timelines.
Works Collaboratively: Integrates diverse cross-functional insights.
Develops People: Supports and mentors team members; invests in self-development.
8. Work Environment
Hybrid model: minimum 3 days per week in-office for collaboration and innovation.
Fast-paced, science-driven environment with a strong focus on oncology and drug innovation.
Opportunity to contribute to AstraZeneca’s goal of eliminating cancer as a cause of death.
9. Why AstraZeneca?
Pioneering science-driven organization
Inclusive and diverse workplace
Strong investment in oncology pipeline
Collaborative culture with freedom to explore, innovate, and grow
Opportunity to impact millions of patients worldwide
10. Call to Action
If you are ready to shape the future of patient safety and influence global regulatory science — apply now and build a meaningful career at AstraZeneca.
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