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Patient Safety Regional Service Director (Jpn)

7-10 years
Not Disclosed
10 Nov. 17, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Patient Safety Regional Service Director (JPN)

Location: Bengaluru, Karnataka, India
Job ID: R-237235
Career Level: F
Date Posted: 09/11/2025
Closing Date: 13/11/2025
Company: AstraZeneca


1. Role Introduction

AstraZeneca aims to impact over 200 million patients and deliver 20 new medicines by 2030.
The Patient Safety Regional Service Director (Japan) is a key leadership role within Global Business Services (GBS), responsible for overseeing the Japan Patient Safety Hub, ensuring excellence in pharmacovigilance, regulatory compliance, service delivery, and process improvement.


2. Key Accountabilities


A. Regulatory Compliance

  • Ensure all Japan Hub activities comply with global and Japan-specific pharmacovigilance regulations.

  • Oversee timely submission of Regulatory Reports.

  • Act as Subject Matter Expert (SME) during audits and inspections concerning case intake and related processes.


B. Leadership & Team Management

  • Maintain adequate staffing and lead recruitment activities when needed.

  • Ensure comprehensive training and development of GBS Patient Safety staff.

  • Manage and guide multiple teams:

    • Team Managers

    • Case Intake

    • Training

    • Quality & Compliance

    • Regulatory Reporting

    • Literature Review

  • Drive performance management and maintain high-quality output.


C. Service Delivery & Process Improvement

  • Oversee daily hub operations including:

    • Case intake

    • Adverse event processing

    • Literature review

    • Regulatory reporting

  • Ensure compliance with Health Authority timelines.

  • Track and analyse case intake metrics; identify performance gaps.

  • Conduct annual update and testing of Business Continuity Process (BCP).

  • Implement and maintain:

    • Quality Management Systems (QMS)

    • SOPs

    • Staff training programs

  • Lead investigation and reporting of PV quality incidents.

  • Align hub processes with global pharmacovigilance standards.

  • Contribute to global and Japan-specific process optimisation and digital/automation improvements.


D. Relationship Management

  • Collaborate with:

    • Other Regional Service Directors

    • Global/Japan Patient Safety teams

    • Internal cross-functional teams

  • Support alignment with broader GBS business goals.

  • Maintain updated knowledge of global & regional regulations and ensure compliance across supported markets.


E. General Responsibilities

  • Commit to ongoing self-development and achievement of personal objectives.

  • Support GBS R&D Teams in project design and implementation.

  • Measure and report on:

    • Intake compliance

    • Reporting performance

    • Employee engagement

    • Process improvement outcomes

  • Ensure services meet or exceed SLAs using metrics-based performance management.

  • Generate reports via MIS tools for decision support.

  • Perform duties as assigned based on business needs.


3. Essential Skills & Experience

Education

  • Bachelor’s degree in a relevant field or equivalent experience.

Experience

  • 7–10 years in pharmacovigilance, including 2–5 years in leadership roles.

  • Strong knowledge of:

    • Global & regional pharmacovigilance regulations

    • Industry standards influencing Global Patient Safety

Capabilities

  • Proven ability to lead transformation projects.

  • Strong ability to manage complexity and multiple priorities under tight deadlines.

  • Effective leadership skills in a multicultural environment.

  • Strong analytical, problem-solving, and decision-making skills.

  • Excellent written and verbal communication.

  • Strong collaboration skills in a matrix environment.

  • Detail-oriented with commitment to quality.


4. Desirable Skills & Experience

  • Higher education: MBA, PhD preferred.

  • Proficiency with safety databases (preferably Argus).

  • Demonstrated success in managing & optimizing patient safety processes.


5. Work Environment

  • Hybrid workplace with minimum 3 days/week in office.

  • Culture of innovation, collaboration, speed, and entrepreneurial mindset.

  • Opportunities to work with cutting-edge digital tools and contribute to large-scale enterprise evolution.


6. Why AstraZeneca?

  • Inclusive, diverse workplace committed to equal opportunity.

  • A global organization with strong values in patient impact, innovation, and scientific leadership.

  • Empowering environment with opportunities for growth and recognition.


7. Call to Action

Ready to make an impact in patient safety and support AstraZeneca’s global mission?
Apply now and be part of a bold and innovative team.