Senior Patient Safety Specialist Job at Parexel (Manila)

Senior Patient Safety Specialist

Parexel

Location:
Philippines , Manila

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Not provided

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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