Senior Manager, Patient Safety Job at Parexel (Hyderabad)

Job Description

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.

Job Responsibility

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
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
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
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
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
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
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

Requirements

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

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Senior Manager, Patient Safety

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