Manager Systems Management

7+ years

Not Disclosed

Spain

10 Dec. 5, 2024

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: Pharmacovigilance Systems Expert
Company: Novartis
Location: Barcelona, Spain (Alternative location: Hyderabad, India)
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular

About the Role

This role involves developing and maintaining IT solutions to meet the evolving needs of Patient Safety and Pharmacovigilance (PV). You will ensure business performance, regulatory compliance, and drive innovation and continuous improvement by managing technical changes, supporting daily operations and audits, and collaborating with both internal and external stakeholders.

Key Responsibilities

Collaboration & Project Management: Partner with PS&PV colleagues to propose new projects, lead business case formation, process assessments, and articulate requirements.
Project Execution: Lead workstreams and manage project execution, defining scope, goals, and objectives, ensuring successful completion of business tasks.
Solutioning & Process Improvement: Guide future improvements by analyzing business processes and facilitating solutioning conversations.
System Ownership: Serve as Product Owner or Business System Owner for pharmacovigilance systems. Oversee their validation, configuration, maintenance, evolution, and ensure appropriate support systems are in place.
Audit Support: Support audits and inspections for PV systems.
Configuration Changes: Lead the implementation and maintenance of system configuration changes, resolve discrepancies, and ensure quality management.
Mentorship & Training: Mentor new Experts or Managers in System Management and provide coaching and training to support team development.

Qualifications

Education: Degree in life science or computing-related field.
Languages: Fluent in English (spoken and written). Additional proficiency in another major European language (French, German, Spanish) is preferred.
Experience:
- Minimum of 7 years of experience in drug development.
- At least 5 years in safety data management and expertise in Pharmacovigilance systems and databases.
Technical Skills:
- Proficient in working with ORACLE databases and skilled with SQL.
- Comprehensive understanding of regulatory requirements for pharmacovigilance.
- Strong knowledge of drug safety business processes.
Soft Skills: Strong communication, collaboration, mentoring, and coaching abilities. Proven track record of leading and delivering initiatives while aligning IT solutions with business needs.

Why Novartis?

At Novartis, we are driven by our purpose to reimagine medicine to improve and extend people’s lives. Join us to be part of a community of passionate individuals who collaborate to achieve breakthroughs that change patients' lives.

Commitment to Diversity & Inclusion

Novartis is committed to creating an inclusive environment with diverse teams that represent the patients and communities we serve.

Benefits and Rewards

Novartis provides a comprehensive benefits package designed to support both personal and professional growth. Learn more about our offerings here.

Join the Novartis Network

If this role isn't the right fit, but you'd like to stay connected and learn about future opportunities, join our talent community here.

For more information about this role or to apply, visit the Novartis Careers page.

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