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Parexel Logo Parexel · IT - Administration

Senior Patient Safety Specialist

Philippines, Manila · Job Posted February 14, 2026
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Job Responsibility

  • Maintain expert-level knowledge of safety profiles, labeling, and global regulations
  • Lead development of project-specific procedures and workflows
  • Provide technical guidance to junior team members
  • Prepare for and participate in audits and inspections
  • Analyze metrics and drive continuous improvement
  • Collaborate with cross-functional teams on safety deliverables
  • Identify risks and recommend mitigation strategies
  • Ensure compliant documentation and archiving
  • Lead project management including safety procedure development and database setup
  • Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)
  • Manage case documentation including narratives, reconciliation, and quality control
  • Generate safety reports, listings, and respond to ad hoc requests
  • Support quality assurance activities, audits, and file maintenance
  • Collaborate with Medical Directors and represent team in client/investigator meetings
  • Delegate tasks appropriately and escalate scope changes to management
  • Assist with resource planning and cross-functional coordination
  • Generate, report, and reconcile compliance metrics in coordination with internal and external stakeholders, as applicable
  • Execute ICSR and periodic report submissions to authorities with expert-level proficiency
  • Manage portal/gateway setup and product registration processes
  • Coordinate unblinding procedures and aggregate report schedules
  • Quality control case reports and listings
  • Develop and refine global safety reporting procedures and systems
  • Analyze compliance metrics and lead quality improvement initiatives
  • Serve as SME in regulatory reporting requirements and represent team in audits
  • Mentor junior staff and contribute to strategic project management
  • Lead client meetings and support cross-functional coordination for timely submissions
  • Develop and maintain comprehensive literature search strategies aligned with client parameters
  • Process citations, review records, and maintain local journal monitoring
  • Perform quality checks on search methodologies and implement thesauri updates
  • Screen publications for adverse drug reactions and potential safety signals
  • Flag relevant findings for medical review and signal detection
  • Resolve literature search issues through stakeholder collaboration
  • Stay current with literature review guidelines and support training initiatives
  • Monitor literature review activities to be aligned with global pharmacovigilance regulations (e.g., EMA, FDA, ICH) and client-specific requirements
  • Serve as primary liaison between global safety operations and local affiliates
  • Maintain product information and reporting rules in client systems
  • Coordinate safety information exchange between headquarters and country offices
  • Ensure local compliance with country-specific pharmacovigilance requirements
  • Support compliance activities including late case investigations
  • Support local health authority interactions and information requests
  • Manage translation requirements for safety documents across regions
  • Coordinate local literature monitoring programs with affiliate teams
  • Support implementation of global safety processes at local level
  • Provide training to affiliate staff on pharmacovigilance procedures
  • Manage follow-ups and query resolution
  • Perform periodic data reconciliation and manage safety communications
  • Participate in regular client meetings
  • Research and maintain drug/device safety reporting regulatory intelligence
  • Conduct country requirement reviews and support QC activities
  • Liaise with authorities to obtain regulatory updates
  • Maintain databases and respond to safety reporting queries
  • Support GPIO team operations and client interactions
  • Ensure compliance with SLAs and KPIs for internal/external clients
  • Provide functional expertise to PV Operations staff
  • Support audits and process improvement initiatives
  • Serve as SME for stakeholders and mentor new team members
  • Stay current with relevant regulations and procedures
  • Disseminate timely and actionable intelligence to internal teams and clients through summaries, alerts, and presentations
  • Work closely with cross-functional teams including Regulatory Affairs, Quality Assurance, and Safety Operations to ensure alignment and integration of regulatory changes
  • Maintain a centralized repository of regulatory intelligence and contribute to the development of SOPs, training materials, and best practices
  • Manage regulatory applications, submissions, and product lifecycle changes in Safety databases
  • Assess regulatory impact for variations and create marketing packages
  • Support global regulatory activities across multiple regions (EU, US, Asia, Middle East, Africa)
  • Perform data remediation for product portfolios during mergers/acquisitions
  • Prepare submission packages and track regulatory documents (RMP, PBRER, HASR, PASS)
  • Validate data against SmPC and manage xEVMPD submissions
  • Create quality control reports and provide technology support
  • Maintain accurate records and perform reconciliation activities

Requirements

  • Expert knowledge of drug safety regulations and pharmacovigilance processes
  • Strong analytical and problem-solving abilities
  • Excellent communication and presentation skills
  • Superior organizational and time management capabilities
  • Proficiency with pharmacovigilance systems and databases
  • Proven experience in safety case management and regulatory reporting
  • Proficiency with safety databases and data analysis
  • Strong knowledge of ICH guidelines and regional requirements
  • Demonstrated mentoring abilities and process improvement skills
  • Experience in pharmaceutical or healthcare environments
  • Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
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