Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role responsible for overseeing end‑to‑end medical device complaint handling and ensuring full compliance with US FDA 21 CFR Part 803 (MDR), Part 820 (QSR), and global post‑market surveillance regulations. The role requires strong expertise in managing complaint intake, investigation, medical evaluation, reportability decisions, regulatory submissions, and closure within defined timelines and quality standards.
This leader will drive operational excellence, partner closely with Quality, Regulatory, R&D, and Manufacturing teams, and ensure robust processes for patient safety, product quality, and regulatory compliance.

Key Accountabilities:

Line Management

• Lead the complete lifecycle of medical device complaint handling and post‑market surveillance.

• Oversee FDA MDR reporting including 5‑Day, 30‑Day, and Supplemental Reports.

• Ensure high‑quality investigations, root cause analysis, and CAPA linkage.

• Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards.

• Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights.

• Support FDA inspections and internal/external audits.

• Manage and mentor a high‑performing complaint operations team.

• Delegate work to Patient Safety staff according to allocated budget/hours

• Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities

• Conduct interviews for recruitment of new personnel as necessary

• Organize, in conjunction with local quality and training staff, mentoring and training (general and on-the-job) for new staff and ensure continuous training within the department and with other departments, where appropriate

• Perform annual appraisals of Patient Safety staff, and provide recommendations for promotions and career development,

• Maintain awareness of any performance issues within the team and taking steps for resolution

• Communicate important decisions/policies discussed with senior management/ client to the team

• Ensuring to meet the requirements as in-Service Level Agreements (SLAs) and achieving all defined and agreed Key Performance Indicators (KPIs) in terms of quality, compliance and trainings

• Develop strategic plans aligned with departmental objectives

• Lead cross-functional initiatives to improve service delivery

• Develop succession plans and career pathways for team members

• Implement talent management strategies across teams

Operational Support for Safety Activities

• Support regional Patient Safety Services alignment with organizational strategy

• Implement resource allocation plans in partnership with Associate Director

• Contribute to Patient Safety Services business plans and process improvements

• Support continuous improvement initiatives for processes and procedures

• Implement pharmacovigilance process enhancements through automation technologies

• Address complex operational challenges across projects

Regulatory Compliance & Quality Management

• Maintain regulatory compliance and quality standards for assigned projects

• Participate in audits and inspections related to pharmacovigilance processes

• Implement compliance and risk mitigation strategies

• Address identified issues from audit reports

• Quality Management System (QMS) overview, project document review, as needed. 

• Contribute to critical issue resolution by providing expert quality advice and direction. 

• Expertly lead project team to investigate root causes and develop robust corrective/preventative actions prior to final audit report review by QA 

• Review all audit/inspection responses prior to final QA review if necessary 

• Stay current with professional standards and safety regulations

• Develop risk management frameworks for projects

Client & Project Management

• Manage specific client projects of moderate complexity

• Maintain client relationships that foster satisfaction

• Implement performance metrics to monitor operational excellence

• Address client concerns and provide feedback to leadership

• Monitor project budgets to support profitability

• Identify and escalate scope changes

• Develop and oversee budgets for multiple projects/teams

• Strategic resource planning across projects

• Develop strategic client relationships to identify new opportunities

• Lead client governance meetings and strategic reviews

Team Leadership

• Supervise team members through day-to-day management

• Participate in recruitment, training, and performance evaluation

• Support team building and motivation

• Ensure team adherence to departmental procedures

• Contribute to training program development

• Support coaching and mentoring as required

• Review timesheets and utilization reports and provide input into monthly reports

Technology and Innovation

• Lead implementation and optimization of pharmacovigilance automation tools and digital solutions

• Develop comprehensive training programs for team adoption of new safety technologies

• Analyze performance metrics of automated safety processes and drive continuous improvement

• Participate in testing and validation of system upgrades and new technology implementations

• Design and deliver technology-related training programs for the patient safety organization

• Lead cross-functional initiatives to accelerate digital transformation in pharmacovigilance

• Assess emerging technologies and recommend implementations to improve safety workflows

• Develop and execute innovation roadmaps to enhance efficiency and compliance through technology

• Manage technology budgets and resource allocation for digital safety initiatives

Business Development Support

• Provide input to proposal generation processes

• Support business development initiatives as needed

• Attend business development meetings when required

• Assist with client presentations

• Participate in stakeholder meetings

Skills:

• Strong clinical, regulatory, and medical Patient Safety Services knowledge

• Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements

• Familiarity with automation/AI in pharmacovigilance

• Adaptable mindset with enthusiasm for learning

• Strong communication and stakeholder management skills

Knowledge and Experience:

• Experience in Patient Safety Services; demonstrated success in clinical, medical, or scientific domains

• People management capabilities with experience leading teams

• Experience in client relationship management

• Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks

• Clinical experience with progressive responsibilities

Education

• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience