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Medical Safety Processes & Projects Lead

10+ years
Not Disclosed
10 Aug. 7, 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, 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

Summary

This role integrates responsibilities in Medical Safety Operations with broad Project Management activities. Reporting to the Head of Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P) Lead will oversee prioritization and planning of deliverables associated with MS-owned processes and key initiatives impacting Medical Safety (MS). You will lead the development and execution of process improvements and other initiatives, ensuring quality and compliance in Medical Safety operations. This position requires driving initiatives for inspection readiness and managing daily operational activities to ensure consistent, high-quality process execution.

About the Role

Major Accountabilities:

  • Leadership and Accountability: Lead and oversee MS-owned or supported processes and IT systems, identifying and addressing gaps or improvement needs such as optimizations, automations, and retirements. Ensure projects result in enhanced performance and compliance with internal and regulatory requirements.

  • Process Improvement: Lead initiatives to safeguard deliverables, quality, and timelines. Support proactive identification of risks and issues, conduct effectiveness checks, and manage metrics to ensure continuous improvement.

  • Subject Matter Expertise: Provide expertise and guidance for process creation, updates, and issue management. Support the Head MS P&P in strategic communications and act as a thought partner and coach for MS P&P Managers to strengthen their skills and professional growth.

  • Transparency and Best Practices: Assist in creating transparency and sharing key learnings and best practices. Support readiness preparations for PV Audits/Inspections and act as a Subject Matter Expert (SME) when needed.

  • Integration and Leadership: Ensure successful integration of mergers and acquisitions into Business As Usual (BAU) operations. Build strong relationships with internal stakeholders and promote compliance through Novartis values.

Minimum Requirements:

  • Education: Advanced degree in Healthcare or Life Sciences (MD, MBBS, MSc, PharmD, PhD preferred).

  • Experience: At least 10 years of project management and/or process ownership experience in a pharmaceutical or healthcare consulting setting, with at least 5 years in a global role. Experience in drug safety (pharmacovigilance), clinical research, or regulatory affairs preferred.

  • Skills:

    • Solid knowledge of drug safety processes, including procedural document authoring and workflow design.
    • Proven ability to work with large, cross-functional teams on complex initiatives.
    • Results-driven with a proactive working style and ability to manage multiple priorities under changing conditions.
    • Excellent communication, negotiation, conflict resolution, decision-making, and problem-solving skills.
    • Strong planning, organizational, and computer skills.

Why Novartis:

At Novartis, our mission goes beyond innovative science. We strive to make a difference by collaborating, supporting, and inspiring one another to achieve breakthroughs that transform patients' lives. If you are ready to join a community of passionate and dedicated professionals committed to creating a brighter future, explore opportunities with us.

Join our Novartis Network:

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Division: Development
Business Unit: Innovative Medicines
Location: Hyderabad, India
Company / Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No