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Associate Director, Patient Safety Scientist

7+ years
Not Disclosed
10 Oct. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Associate Director, Patient Safety Scientist at AstraZeneca

Job ID: R-211223
Date Posted: 10/21/2024
Global Career Level: E

Introduction to Role

Join AstraZeneca as an Associate Director, Patient Safety Scientist, where you'll work collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and documents for potential safety issues. This role involves authoring and providing pharmacovigilance input to safety documents and regulatory reports, as well as leading meetings and presenting safety data.

Accountabilities

  • Proactive Pharmacovigilance: Lead risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans.

  • Cross-Functional Representation: Act as the Patient Safety representative on project teams for marketed products and developmental compounds.

  • External Presentations: Present safety information at external meetings.

  • Data Evaluation: Lead data evaluation and discussions at the Safety Information Review Committee (SIRC) and produce accurate evaluation documents in response to requests for safety data.

  • Safety Information Collaboration: Work with GSP and Clinical representatives to author Reference Safety Information (RSI) for assigned products.

  • Clinical Evaluation: Proactively evaluate clinical implications of safety data to establish drug safety profiles.

  • Regulatory Document Preparation: Author and provide strategic input for periodic regulatory documents (PBRERs, PSURs, DSURs).

  • Training and Mentoring: Train junior team members in Patient Safety tools and systems.

Essential Skills/Experience

  • Educational Background: Degree in biosciences or a related field with competency in patient safety and clinical development.

  • Regulatory Knowledge: Comprehensive understanding of Patient Safety regulatory obligations and policies.

  • Experience: 9 to 11 years in Patient Safety, totaling 12 to 14 years of experience.

Communication and Leadership Skills

  • Interpersonal Skills: Well-developed interpersonal skills and cultural sensitivity.

  • Strategic Thinking: Ability to apply broad perspectives and adapt approaches.

  • Decisive Action: Make effective decisions under pressure and seek support when needed.

  • Performance-Driven: Hold the team accountable to quality standards and clarify objectives.

Why AstraZeneca?

At AstraZeneca, we’re dedicated to pushing the boundaries of science to transform the lives of patients. Join our pioneering team and help us eliminate cancer as a cause of death. We foster a collaborative environment that encourages smart risks, challenges norms, and values diverse perspectives.

Ready to Make a Difference?

If you’re ready to bring new ideas and fresh thinking to the table, we want to hear from you!

Explore More About Us:

AstraZeneca embraces diversity and equality of opportunity. We welcome applications from all qualified candidates and comply with all applicable laws and regulations on non-discrimination in employment.