Job Title: Medical Director, Patient Safety Physician
Career Level: E
Role Overview
Are you ready to make a meaningful impact on patients' lives? As Medical Director, Patient Safety Physician, you will play a pivotal role in ensuring the safety of AstraZeneca’s drugs throughout all stages of their lifecycle—from clinical development to market. You will provide strategic leadership in clinical safety, leveraging your medical expertise to manage and evaluate safety profiles, contributing to regulatory documentation, and participating in key internal and external meetings.
This is an exciting opportunity to be part of AstraZeneca’s Research & Development team in Biopharmaceuticals R&D, shaping the future of healthcare and making a real difference to patients worldwide.
Key Accountabilities
Safety Surveillance and Strategy
Lead clinical safety strategy for assigned drug projects and products.
Conduct medical reviews of individual safety cases and adverse event data.
Perform signal detection, evaluation, and provide inputs for Safety Information Review Committee (SIRC) activities.
Offer medical expertise for regulatory submissions, including labelling updates and risk management plans.
Collaboration and Communication
Collaborate with cross-functional teams during internal project meetings.
Represent AstraZeneca in external regulatory and non-regulatory meetings, including consultations and interactions with licensing partners.
Prepare and contribute to licensing agreements in therapeutic areas of responsibility.
Regulatory and Compliance
Ensure compliance with global regulatory requirements and best practices for expedited and periodic safety reporting, signal generation, and safety evaluation.
Contribute to AstraZeneca’s reputation for excellence in pharmacovigilance and patient benefit-risk assessment.
Essential Qualifications and Experience
Education: Medical degree (e.g., MD, MBBS).
Clinical Experience: Minimum 2 years of post-registration clinical experience (preferred).
Industry Expertise:
15+ years of experience, with at least 11–13 years in Patient Safety, including a strong record of delivery.
5+ years of experience managing and leading teams.
In-depth knowledge of the pharmaceutical/biopharmaceutical industry, including clinical research and global regulatory frameworks governing safety and risk management.
Technical Expertise:
Excellence in pharmacovigilance, patient benefit-risk assessment, and application of disease/therapeutic area knowledge.
Comprehensive understanding of drug development processes.
Key Competencies
Leadership: Strategic leadership, decision-making, collaboration, and organizational development.
Technical: Strong skills in signal detection, integrative thinking, and safety strategy execution.
Core Skills: Conceptual thinking, innovation, influencing, initiative, and business relationship management.
Why Join AstraZeneca?
At AstraZeneca, we are dedicated to pushing the boundaries of science to develop life-changing medicines. Our Biopharmaceuticals R&D team is at the forefront of integrating cutting-edge data and technology with scientific innovation, creating opportunities to treat, prevent, and even cure some of the world’s most complex diseases.
Working with us means collaborating in a diverse and inclusive environment where innovative thinking and teamwork are celebrated. In-person collaboration allows us to connect, challenge perceptions, and work effectively at pace, balancing office presence with individual flexibility.
Next Steps
Are you ready to push the boundaries of science and deliver life-changing medicines? Apply now and join a team where your contributions will make a significant impact on patients’ lives around the world.
Diversity and Inclusion at AstraZeneca
We embrace diversity and equality of opportunity, building an inclusive team representing a broad spectrum of backgrounds, perspectives, and industry-leading skills. We comply with all applicable laws on non-discrimination, work authorization, and employment eligibility verification.
Join us at AstraZeneca, where we follow the science and shape the future of healthcare.
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