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Manager - Patient Safety Systems

5+ years
Not Disclosed
10 Jan. 31, 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

📌 Manager - Patient Safety Systems | AstraZeneca – Bangalore, India

💼 Company: AstraZeneca
📍 Location: Bangalore, India
🕒 Job Type: Full-Time
🌍 Category: Life Sciences & Healthcare

Role Overview

AstraZeneca is seeking a Manager - Patient Safety Systems to join their Global Patient Safety Technical Solutions (PSTS) team, responsible for managing pharmacovigilance (PV) systems and technologies. The ideal candidate will contribute to the design, installation, and maintenance of PV systems, primarily working with Oracle’s ARGUS platform. This role requires a strong background in systems management, quality management, and ideally pharmacovigilance, with a focus on system validation and project management.

Key Responsibilities

  • Contribute to the development and design of PV systems to meet regulatory and business requirements.
  • Oversee the installation and maintenance of PV system components, ensuring compliance with industry standards.
  • Provide technical support to users and partners, including IT teams.
  • Manage system updates and technology upgrades for optimal performance.
  • Ensure compliance with local, state, and federal regulations, maintaining detailed documentation.
  • Train and educate team members on the operation of PV systems.
  • Collaborate across regions and organizations to manage vendor and customer relationships.

Candidate Requirements

🎓 Education & Experience:

  • Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy) with experience in safety-related activities.
  • Experience in systems design, delivery, deployment, or maintenance of information systems.
  • Knowledge or experience with validated computerized systems, especially in patient safety/pharmacovigilance.
  • Experience in system validation.

💼 Desirable Skills:

  • Higher degree in clinical or safety-related discipline.
  • Experience with Commercial Off the Shelf (COTS) PV systems (e.g., ARGUS, ArisGlobal, Veeva).
  • Strong communication and interpersonal skills to influence alignment and agreement.
  • Business awareness of PV system design, development, and deployment in the pharmaceutical industry.

Why AstraZeneca?

AstraZeneca is a global, research-led biopharmaceutical company that emphasizes diversity, innovation, and collaboration. They provide a dynamic environment for personal growth, professional development, and opportunities for global mobility. With a commitment to inclusive culture and continuous learning, AstraZeneca fosters a place where employees can thrive and make a meaningful impact on healthcare and society.

How to Apply

Interested candidates can apply by submitting their application before the closing date: February 14, 2025.