Medical Director, Patient Safety Physician

15+ years

Not Disclosed

Remote

10 Feb. 16, 2025

Job Description

Job Type: Full Time Education: MD/MBBS 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: 02/12/2025
Career Level: E

Introduction to Role:

Are you ready to make a meaningful impact on patients' lives? We are seeking a Medical Director, Patient Safety Physician to join our dedicated Research & Development team in Biopharmaceuticals R&D. This role is responsible for the Clinical Safety strategy for assigned AstraZeneca drug projects and products throughout all stages of development and/or when on the market. You will be responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products.

Accountabilities:

As a Medical Director, Patient Safety Physician, you will be involved in all safety surveillance activities, which may include medical review of individual safety cases (providing medical expertise and judgment), signal detection, evaluation, and SIRC activities for all products in the area of responsibility. You will provide medical input to regulatory supporting documentation for labeling updates and contribute to the preparation of licensing agreements in the therapeutic area of responsibility. You will also participate in AstraZeneca internal meetings with project focus and external regulatory and non-regulatory meetings, including those with consultants and other companies such as licensing partners.

Essential Skills/Experience:

Medical degree (e.g., MD, MBBS)
At least 2 years of clinical experience post-registration preferred
High level of medical competence
Up to 11-13 years of Patient Safety experience (with clear evidence of delivery)
5 years of team handling experience
Total 15+ years of experience
A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities

Leadership Skills:

Commitment to Customers and Integrity
Strategic Leadership
Acts Decisively
Drives Accountability
Works Collaboratively
Develops People and Organization

Technical Skills:

Drug Development Experience and Application of Disease and TA knowledge
Integrative Thinking
Excellence in Pharmacovigilance
Patient Benefit-Risk Assessment

Core Skills:

Conceptual Thinking
Influencing
Initiative
Innovation
Business Relationship Management

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Are you ready to push the boundaries of science to deliver life-changing medicines? Are you passionate about making an impact on patients' lives? If so, join us at AstraZeneca where we are driven by our desire to understand and reveal new insights. Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Medical Director, Patient Safety Physician

Job Description

Introduction to Role:

Accountabilities:

Essential Skills/Experience:

Leadership Skills:

Technical Skills:

Core Skills:

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