Job Title: Medical Director, Patient Safety Physician
Role Summary
As a Medical Director, Patient Safety Physician at AstraZeneca-MedImmune, you will oversee the clinical safety strategy for assigned drug projects and marketed products across all stages of development and post-marketing. Your responsibilities will include implementing and communicating safety strategies, continuous assessment of safety data, and managing risk while ensuring adherence to regulatory standards. By evaluating and mitigating risks, you will help establish robust safety profiles for the company’s innovative therapies.
Key Responsibilities
Safety Governance and Risk Management
Develop and implement the clinical safety strategy for AstraZeneca-MedImmune projects and marketed products.
Act as a key representative on cross-functional teams, providing medical and safety expertise.
Review and endorse core Patient Risk Management Plans (PRMPs) and Core Patient Risk Logs (CPRLs).
Provide input on the medical content of risk management activities, including safety specifications and pharmacovigilance plans.
Ensure risk-minimization strategies are appropriately reflected in product reference safety information.
Contribute to clinical development planning and project-specific safety requirements.
Review and provide input for investigator brochures, protocols, informed consents, study reports, and external data monitoring committees.
Signal Detection, Evaluation, and Labelling
Participate in safety surveillance activities, including signal detection and evaluation.
Provide medical expertise in the review of individual safety cases and signal management.
Collaborate on the creation and update of regulatory safety documentation, including labelling updates.
Identify and utilize data sources for safety signal evaluation and regulatory responses.
Prepare Developmental Core Safety Information (DCSI) for developmental products.
Regulatory Reporting and Submissions
Provide medical input and review for periodic reports, including PBRERs, PSURs, and DSURs.
Contribute to the preparation and review of safety sections in regulatory submissions (NDA, BLA, MAA).
Essential Qualifications
Medical degree (e.g., MD, MBBS).
Minimum of 3 years of clinical experience post-registration.
At least 2 years of experience in drug development or patient safety in the pharmaceutical industry.
High level of medical expertise and ability to balance business goals with patient safety.
Desirable Qualifications
Advanced degree (MSc/PhD) in a scientific discipline.
Ability to work across multiple therapy areas and functions.
Experience supervising patient safety teams.
Familiarity with epidemiological data and its application to safety assessments.
Why Join AstraZeneca?
At AstraZeneca, you will be part of a global community focused on transformative healthcare solutions. Our pioneering work is powered by innovation, collaboration, and the shared goal of delivering life-changing medicines. By joining our team, you will gain the opportunity to work on cutting-edge therapies, contribute to pandemic preparedness, and make a meaningful difference in the lives of millions.
We foster a dynamic and inclusive culture, combining diverse talents with cutting-edge technology. With a hybrid work model offering flexibility, AstraZeneca supports a collaborative environment where bold ideas thrive.
Next Steps
Are you ready to make a difference? Join AstraZeneca and help shape the future of healthcare. Apply now to be part of a team committed to innovation, collaboration, and life-changing science.
AstraZeneca is an equal opportunity employer committed to diversity, inclusion, and non-discrimination in recruitment, employment, and compliance with all applicable laws.
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