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.
About the Role: This position can be based in Barcelona, Spain.
The Medical Safety and Processes Manager will provide operational planning/execution support to assigned process development/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 (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.
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.
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