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Medical Director, Patient Safety Physician

2+ years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: MBBS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Director, Patient Safety Physician
Job ID: R-205519
Date Posted: 12/10/2024
Career Level: E

Introduction:
Are you passionate about making a significant impact on patients' lives? We are looking for a Medical Director, Patient Safety Physician to join our dynamic Research & Development team in Biopharmaceuticals R&D. In this role, you will oversee the Clinical Safety strategy for AstraZeneca drug projects and products at all stages of development and post-market. You will play a key role in the ongoing evaluation of adverse events and other safety data to manage and predict the safety profiles of compounds in clinical development and marketed products.

Key Responsibilities:

  • Lead safety surveillance activities, including medical review of individual safety cases, signal detection, evaluation, and SIRC activities for all products within your area of responsibility.
  • Provide medical input for regulatory documentation to support labeling updates and contribute to licensing agreements in your therapeutic area.
  • Participate in internal meetings with project teams and external meetings with regulatory bodies, consultants, and licensing partners.

Essential Skills & Experience:

  • Medical degree (MD, MBBS, or equivalent).
  • Minimum of 2 years of clinical experience post-registration preferred.
  • 11-13 years of Patient Safety experience with clear evidence of delivery, including 5 years in a team leadership role.
  • A comprehensive understanding of the pharmaceutical/biopharmaceutical industry, clinical research, and global regulatory practices related to safety reporting, signal generation, and risk management.
  • Strong leadership capabilities: commitment to customers, strategic leadership, decision-making, accountability, collaboration, and organizational development.
  • Technical expertise in drug development, pharmacovigilance, patient benefit-risk assessment, and disease-specific knowledge.
  • Strong core skills in conceptual thinking, influencing, innovation, and business relationship management.

Our Work Culture:
At AstraZeneca, we believe that by bringing diverse teams together, we can spark bold ideas and drive life-changing advancements in medicine. Our approach to in-person work allows us to collaborate, challenge each other, and move quickly. While we expect a minimum of three days per week in the office, we respect individual flexibility and aim to strike a balance between collaboration and personal flexibility.

Our Mission:
We are committed to pushing the boundaries of science to treat, prevent, modify, and even cure some of the world's most complex diseases. By combining cutting-edge data, technology, and scientific innovation, we are pioneering breakthroughs that can positively impact the lives of billions of patients.

Are You Ready to Make a Difference?
If you are driven by a passion for science and the desire to make a lasting impact on patients’ lives, apply now to join AstraZeneca. Together, we can drive the next wave of medical advancements.