Manager Systems Management

5+ years

Not Disclosed

Hyderabad

10 Dec. 10, 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

Novartis Global Pharmacovigilance System Manager – Barcelona, Spain / Hyderabad, India
Innovative Medicines, Research & Development

About Novartis
At Novartis, we are dedicated to reimagining medicine to improve and extend the lives of patients worldwide. Our mission is driven by collaboration, innovative science, and a commitment to improving the health of patients everywhere. We believe that breakthroughs in medicine come from combining diverse perspectives and expertise, and we foster an inclusive, empowering work environment for our employees.

Role Overview
The Global Pharmacovigilance System Manager is responsible for implementing and managing global processes and technologies to ensure compliant reporting of Individual Case Safety Reports (ICSRs) across all platforms. You will oversee the timely distribution, reporting, and quality compliance of ICSRs in accordance with regulatory requirements, ensuring adherence to safety standards and promoting continuous improvements.

Key Responsibilities

Act as the super user for the reporting system (T-Rex), providing expertise and guidance to end-users and stakeholders.
Serve as the Business System Owner or Deputy, managing global strategic initiatives and solutions for Patient Safety and Pharmacovigilance.
Coordinate the implementation and submission of ICSRs to Health Authorities, Country Organizations, and License Partners, ensuring compliance with regulatory standards.
Lead or contribute to global technical projects, cross-functional workshops, and the development, testing, and validation of safety systems and IT applications.
Manage outsourced tasks to service vendors, ensuring compliance and effective vendor training.
Identify gaps in ICSR reporting compliance and propose solutions, ensuring inspection readiness and supporting Health Authority inspections and internal audits.

What You’ll Bring to the Role

Degree in life sciences, computing, or related field.
Minimum of 7 years in drug development, with at least 5 years focused on safety data management and expertise in Pharmacovigilance systems.
Strong understanding of reference data for Pharmacovigilance (e.g., medical dictionaries, product/device definitions).
Extensive knowledge of Pharmacovigilance and Drug Safety business processes.
Proven ability to mentor and lead cross-functional teams to deliver results and drive initiatives.

Why Novartis?
Novartis is passionate about helping people by combining cutting-edge science with innovative approaches. As a member of our team, you will collaborate with talented individuals who share a common goal: improving patient lives and achieving breakthroughs. We are committed to fostering an inclusive culture where everyone can thrive.

Location Options

Barcelona, Spain
Hyderabad, India

Benefits and Rewards
Discover the comprehensive benefits and rewards that help our employees thrive personally and professionally. Learn more in our Benefits Handbook.

Commitment to Diversity & Inclusion
Novartis values diversity and is committed to building an inclusive, equitable work environment where all employees can grow and succeed.

Join Our Novartis Network
If this role isn't the perfect fit for you, stay connected by joining our talent community. Be the first to know about upcoming opportunities: Join Novartis Talent Network.

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Manager Systems Management

Job Description

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