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Gbs Patient Safety Hub Director

5-8 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: GBS Patient Safety Hub Director

Location: Bangalore, India
Job ID: R-224005
Job Type: Full-time
Company: AstraZeneca
Application Deadline: April 14, 2025
Date Posted: April 11, 2025


Introduction to Role:

As AstraZeneca strives to deliver 20 new medicines by 2030 and improve the lives of 200 million patients, the GBS Patient Safety Hub Director plays a pivotal role in driving this mission. This leadership position involves overseeing the GBS Patient Safety Hub in Bangalore, which manages adverse event case processing, literature reviews, and regulatory reporting. The position leads a team of 80+ professionals and plays a key role in ensuring regulatory compliance and service delivery excellence.


Key Accountabilities:

Regulatory Compliance

  • Ensure adherence to global pharmacovigilance regulations and timely regulatory report submissions

  • Serve as a subject matter expert during inspections/audits

Leadership & Team Management

  • Maintain optimal staffing levels and manage recruitment

  • Train and develop staff for compliant, standardized performance

  • Lead multiple teams, including Training, Quality & Compliance, Regulatory Reporting, and Literature Review

Service Delivery & Process Improvement

  • Oversee daily operations of the hub, ensuring quality and compliance

  • Monitor performance metrics and lead process improvement initiatives

  • Standardize SOPs and contribute to global patient safety systems and tools

  • Drive business continuity and automation efforts

Relationship Management

  • Collaborate with global GBS and Patient Safety teams for process alignment

  • Work closely with internal partners to meet broader GBS goals

General

  • Stay updated on industry standards, regulations, and trends

  • Collaborate with GBS R&D teams on projects and innovation

  • Ensure compliance with regional pharmacovigilance regulations


Essential Skills/Experience:

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

  • Experience: 5–8 years in pharmacovigilance, including leadership roles

  • Deep knowledge of global and regional PV regulations

  • Demonstrated ability to lead transformational programs

  • Strong leadership, communication, and team development skills

  • Experience in managing metrics, audits, and cross-functional collaboration

  • Strong analytical, problem-solving, and organizational skills

  • Fluent in English; excellent communication skills

  • Experience working in complex matrix environments


Desirable Skills/Experience:

  • Education: Advanced degree (MBA, PhD) preferred

  • Experience with Argus and other safety databases

  • Proven success in optimizing patient safety processes


Work Environment:

  • Hybrid work model: Minimum 3 days in-office per week

  • Encourages collaboration, innovation, and cross-functional teamwork

  • Values diversity and offers an inclusive, empowering environment