03 Dec | ES06 (FCRS = ES006) Novartis Farmacéutica | Barcelona 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 the Medical Safety Officer.
The role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance (PV) needs) with Project Management activities.
Reporting to the Head Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P;) Manager is responsible for planning deliverables associated with MS owned processes and other key initiatives impacting MS.
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 (and where applicable, IT systems) maintenance and/or improvements.
Your key responsibilities: 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 which can be addressed through projects and support development of the appropriate business case.
Exhibit leadership and accountability for assigned initiatives provisioned, led, or supported by Medical Safety Operations to safeguard deliverables, quality, as well as timelines including necessary support.
Support or lead compliance in assigned activities and challenge 'as-is' 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 & support for process creation and/or updates including management of Medical Safety related process issues (both internal and external).
Support Head MS P&P; in communications related to process changes and other key initiatives as applicable.
Support team in creating transparency and sharing key learnings and best practices for continuous processes, projects, and/or departmental improvement.
Provide support and/or deputize for MS P&P; Lead as needed.
Support readiness preparations for PV Audits/Inspections and provide support during PV Audits/Inspections including acting as SME where applicable.
Foster strong relationships with key internal stakeholders and customers through demonstrating company values (inspired, curious, unbossed, and self-aware) in Medical Safety.
What you'll bring to the role: At least 6 years of project management (at least 2 years as a project leader) and/or Process ownership experience in a pharmaceutical or healthcare consulting setting, preferably in drug safety (i.e., Pharmacovigilance), clinical research, or regulatory affairs.
Solid knowledge in drug safety related processes (including authoring procedural documents, workflow design).
Proven ability to work with cross-functional teams in initiatives.
Results-driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.
Proven ability for clear and concise communication tailored to a diverse audience and effective cross-functional collaboration, stakeholder engagement, and teamwork.
Sense of urgency and ability to manage multiple priorities under a changing environment.
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 building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to ****** and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.
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