Medical Safety Processes And Projects Manager

Summary This 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 of deliverables associated with MS owned processes and other key initiatives impacting MS The MS P P Manager will lead and provide operational planning execution support to assigned process development improvement activities related to Medical Safety provisioned led and or supported by MSO The MS P P Manger 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 Major Activities 1 Lead and coordinate Medical Safety MS owned supported processes and IT systems with support of Process and Projects Lead as applicable in conducting regular reviews to identify improvement needs e g optimizations retirements automations etc which can be addressed through projects and support development of the appropriate business case projects should result in improved performance incl quality and or compliance considering internal and external regulatory requirements 2 Exhibit leadership and accountability for assigned initiatives provisioned led or supported by Medical Safety Operations MSO to safeguard deliverables quality as well as timelines incl necessary support e g deputy identification for processes and appropriate knowledge transition 3 Support or lead compliance in assigned activities and challenge as-is for continuous improvement and assure inspection readiness 4 Support or lead proactive identification of risks issues via close monitoring of assigned processes incl conductance of effectiveness checks and monitoring of metrics 5 Provide subject matter expertise guidance support for process creation and or updates incl management of Medical Safety related process issues both internal and external 6 Support Head MS P P in communications related to process changes and other key initiatives as applicable 7 Support team in creating transparency and sharing key learnings and best practices for continuous processes projects and or departmental improvement 8 Provide support and or deputize for MS P P Lead as needed e g process ownerships 9 Support readiness preparations for PV Audits Inspections and provide support during PV Audits Inspections incl act as SME where applicable 10 Foster strong relationships with key internal stakeholders and customers through demonstrating company values inspired curios unbossed and self-aware in Medical Safety 11 Ensure completion of applicable trainings in a timely manner Key Performance Indicators Efficient projects and process maintenance based on assignment priorities importance and requirements Timeliness of deliverables according to established directives Quality of work delivered attention to important details thoroughness scientifically sound Moderate level of independence Value of contribution as a Subject Matter Expert for Medical Safety function work streams and initiatives Effectiveness and efficiency of management execution of PS PV work streams and initiatives Impact on the organization Ensures value generation for Medical Safety and PS PV in general through an effective and efficient operational execution and support of processes and projects owned by MS and other functions as applicable Education Advanced degree or equivalent education in Healthcare Life Sciences is preferred such as MD MBBS MSc Pharm D PhD Languages Fluent in spoken and written English Experience Required professional experience At least 6 years of at least 3 years in a global role 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 incl 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 Quality oriented Proven ability for clear and concise communication tailored to a diverse audience and effective cross functional collaboration stakeholder engagement and teamwork Very good planning organizational and computer skills Sense of urgency and ability to manage multiple priorities under a changing environment Good negotiation conflict resolution decision making problem solving and presentation skills Skills Desired Clinical Research Clinical Trials Functional Teams Literature Review Medical Records Process Safety Regulatory Compliance Safety Science