Project Execution Expert (M / F / D)

Medical Safety Processes and Projects Manager

Job ID : REQ-10017856

Location : Spain

Summary

Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.

About the Role

This position can be based in Barcelona, Spain. The Medical Safety and Processes Manager will provide operational planning and execution support to assigned process development and improvement activities related to Medical Safety provisioned, led and / or supported by Medical Safety Officer.

The role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance needs) with Project Management activities. Reporting to the Head Medical Safety Processes & Projects, the MS Processes and Projects Manager is responsible for planning deliverables associated with Medical Safety owned processes and other key initiatives impacting Medical Safety.

The successful candidate is accountable to ensure adequate quality and compliance in relation to process executions (with or without involvement of IT systems) in Medical Safety through driving their assigned initiatives as well as inspection readiness via process maintenance and / or improvements.

Your key responsibilities include :

• Lead and coordinate Medical Safety owned processes (and IT systems) with support of Process and Projects Lead in conducting regular reviews to identify improvement needs.
• Exhibit leadership and accountability for assigned initiatives provisioned, led or supported by Medical Safety Operations to safeguard deliverables, quality, and timelines.
• Support or lead compliance in assigned activities and challenge current processes for continuous improvement and assure inspection readiness.
• Support or lead proactive identification of risks / issues via close monitoring of assigned processes.
• Provide subject matter expertise, guidance, and support for process creation and / or updates including management of Medical Safety related process issues.
• Support Head MS Processes and Projects in communications related to process changes and other key initiatives.
• Support team in creating transparency and sharing key learnings and best practices for continuous improvement.
• Provide support and / or deputize for MS Processes and Projects Lead as needed.
• Support readiness preparations for Pharmacovigilance Audits / Inspections and provide support during these audits / inspections.
• Foster strong relationships with key internal stakeholders and customers through demonstrating company values.

What you’ll bring to the role :

• At least 6 years of project management experience (with at least 3 years in a global role) and / or process ownership in a pharmaceutical or healthcare consulting setting, preferably in drug safety.
• Solid knowledge in drug safety related processes.
• Proven ability to work with cross-functional teams.
• Results-driven, self-starter with proactive working style.
• Proven ability for clear and concise communication tailored to a diverse audience.
• Sense of urgency and ability to manage multiple priorities.
• Good negotiation, conflict resolution, decision making, problem solving, and presentation skills.

Education : Advanced degree or equivalent education in Healthcare / Life Sciences. MD, MBBS, MSc, Pharm D, PhD preferred.

Languages : Fluent in spoken and written English.

Why Novartis?

Novartis is committed to improving and extending people's lives through innovative solutions.

Commitment to Diversity & Inclusion :

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation :

Novartis is committed to providing reasonable accommodation to all individuals. If you need a reasonable accommodation for any part of the recruitment process, please send an e-mail with your request.

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