Medical Safety Process & Project Manager

Job Description Summary

Are you passionate about shaping how patient safety is delivered at scale? In this role, you will sit at the heart of Global Medical Safety, driving meaningful process and project initiatives that directly strengthen quality, compliance, and inspection readiness worldwide. As Medical Safety Processes and Projects Manager, you will partner closely with cross-functional experts to improve how safety operations work, lead impactful initiatives from concept to execution, and challenge the status quo to continuously raise standards.

This is an opportunity to combine scientific understanding, process excellence, and project leadership to make a real difference for patients globally—every day.

 

Job Description

Location: Barcelona, Spain

Working model: Hybrid

#LI-Hybrid 

Relocation Support: Novartis is unable to offer relocation support: please only apply if this location is accessible to you.

Key Responsibilities 

• Lead Medical Safety processes and systems, identifying improvement opportunities that enhance quality, performance, and regulatory compliance. 

• Plan and execute process improvement and project initiatives, building strong business cases and delivering measurable outcomes. 

• Ensure high-quality, timely delivery of Medical Safety initiatives through clear ownership, governance, and proactive risk management. 

• Drive continuous improvement by challenging existing practices and strengthening inspection readiness across Medical Safety operations. 

• Monitor process effectiveness through metrics, reviews, and controls, proactively identifying risks, issues, and mitigation actions. 

• Provide subject matter expertise for Medical Safety processes, including development, updates, and resolution of complex process issues. 

• Support and lead readiness activities for pharmacovigilance audits and inspections, acting as subject matter expert when required. 

• Partner with global, cross-functional stakeholders to align initiatives and embed best practices across Medical Safety. 

• Support clear communication of process changes and key initiatives, ensuring transparency and shared learning across teams. 

•  Deputise for the Medical Safety Processes and Projects Lead when needed, ensuring continuity of ownership and expertise. 

Essential Requirements 

• Advanced degree in healthcare or life sciences (such as MD, MBBS, MSc, Pharm D, PhD). 

• At least three to four years of Pharmacovigilance project management and/or process ownership experience, including three years in a global role ideally in drug safety (PV), clinical research, or regulatory affairs.

• Fluent English (both written and spoken) with the ability to communicate clearly across global, cross-functional teams. 

• Working knowledge of PV / drug safety processes and how they translate into workflows + procedural documents.

• Strong project leadership and process ownership discipline.

• Compliance and inspection-readiness mindset.

• Ability to operate in a global matrix and influence without authority

• High quality mindset, attention to detail and timeliness 

Desirable Skills 

* Local language competency would be an advantage. 

* Hands-on Pharmacovigilance (PV) / Medical Safety experience (eg- Aggregate Analysis, Individual Safety Cases)

* Experience supporting PV audits/inspections.

* Strength in PV process design and documentation.

* Data-driven process monitoring expertise.

* Experience partnering with IT on process-enabled systems.

If you are excited to shape how Medical Safety processes evolve globally and want your work to have real impact on patient safety, we encourage you to apply. Join us and help reimagine how we deliver safety excellence—together. 

 

Skills Desired

Clinical Research, Clinical Trials, Functional Teams, Literature Review, Medical Records, Process Safety, Regulatory Compliance, Safety Science