Job Title: Director, Principal Patient Safety Scientist
Location: Bengaluru
About AstraZeneca
At AstraZeneca, we deliver life-changing medicines to millions of people globally. By fostering an inclusive and innovative culture, we push the boundaries of science to develop a robust pipeline of transformative medicines. Our Oncology R&D business area focuses on predicting, preventing, and treating complex diseases with cutting-edge digital and analytical technologies to deliver improved patient outcomes.
Role Overview
As the Director, Principal Patient Safety (PS) Scientist, you will lead proactive pharmacovigilance (PV) and risk management strategies for multiple complex products within the Oncology Therapeutic Area. Collaborating with the Global Safety Physician (GSP) and other PV Scientists, you will help shape the culture of the safety team and broader Patient Safety Therapeutic Area (PSTA) function. This role offers a dynamic opportunity to contribute to a pipeline of innovative oncology therapies while working across AstraZeneca’s multidisciplinary teams and external stakeholders.
Key Accountabilities
Strategic Leadership
Provide subject matter expertise and leadership in the therapeutic area and across product portfolios.
Develop and implement safety surveillance strategies, presenting complex safety issues to cross-functional teams, governance committees, and regulatory bodies.
Partner with the GSP and specialists to lead safety strategies for regulatory submissions, including NDA/BLA and MAA filings.
Drive PV components of contracts and agreements with third parties during due diligence activities.
Team and Culture Development
Mentor and train PV Scientists and junior physicians to build expertise within the team.
Foster collaboration within the team and across clinical project teams, regulatory affairs, and commercial groups.
Promote an inclusive and innovative culture, facilitating knowledge sharing and best practice adoption.
Operational Excellence
Oversee the development of periodic safety reports, risk management plans, and responses to health authority queries.
Ensure compliance with PV regulations and industry best practices while managing multiple complex projects.
Actively participate in governance board discussions and strategic decision-making processes.
Essential Qualifications and Skills
Education: Bachelor’s degree in sciences, pharmacy, nursing, or a related field.
Experience: 7+ years of relevant experience in PV or clinical/drug development, including:
Proactive risk identification and mitigation in clinical development (Early/Late Phase).
Signal detection and evaluation in post-marketing surveillance.
Leading safety-related aspects of MAA/BLA submissions and periodic safety reports.
Authoring risk management plans and participating in governance boards.
Expertise: Advanced knowledge of PV regulations and exceptional project management skills.
Language: Proficiency in written and verbal English.
Ability to manage multiple projects, prioritize effectively, and work in a matrixed environment.
Desirable Qualifications and Skills
Advanced degree (MS or PhD) in a scientific field.
5+ additional years of experience in PV or drug development.
Strong industry network and extensive knowledge of technical and regulatory developments.
Compensation and Benefits
The annual base pay for this position ranges from $177,270 to $265,905, based on factors such as market location, experience, and qualifications. Additional benefits include:
Short-term incentive bonus opportunities.
Eligibility for equity-based long-term incentive programs (salaried roles).
Health benefits: Medical, dental, vision, prescription drug coverage.
Retirement programs: 401(k) plan with employer contribution.
Paid vacation, holidays, and leave.
In-Office Requirement
To foster collaboration and innovation, this role requires an average of three days per week in the office. AstraZeneca balances in-office expectations with respect for individual flexibility.
Why AstraZeneca?
At AstraZeneca, we strive to shape the future of healthcare by embracing technology, digital innovation, and diversity. As part of the Oncology R&D team, you’ll play a critical role in delivering transformative medicines and improving patient outcomes. Join a collaborative, inclusive environment that inspires bold thinking and continuous learning.
Next Steps
Envision yourself making a difference? We look forward to hearing from you!
For more details, visit AstraZeneca Careers.
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