The Senior Patient Safety Specialist provides advanced support and leadership across global pharmacovigilance activities in both clinical trial and post-marketing settings. This role contributes expert-level knowledge and oversight to safety reporting processes, ensuring compliance with international regulations and internal standards. Responsibilities include mentoring junior staff, optimizing workflows, and collaborating cross-functionally to drive quality and efficiency in safety deliverables.
Key Accountabilities:
General
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Maintain expert-level knowledge of safety profiles, labeling, and global regulations
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Lead development of project-specific procedures and workflows
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Provide technical guidance to junior team members
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Prepare for and participate in audits and inspections
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Analyze metrics and drive continuous improvement
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Collaborate with cross-functional teams on safety deliverables
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Identify risks and recommend mitigation strategies
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Ensure compliant documentation and archiving
ICSR Processing
- Lead project management including safety procedure development and database setup
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Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)
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Manage case documentation including narratives, reconciliation, and quality control
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Generate safety reports, listings, and respond to ad hoc requests
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Support quality assurance activities, audits, and file maintenance
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Collaborate with Medical Directors and represent team in client/investigator meetings
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Delegate tasks appropriately and escalate scope changes to management
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Assist with resource planning and cross-functional coordination
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Generate, report, and reconcile compliance metrics in coordination with internal and external stakeholders, as applicable
Safety Submissions
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Execute ICSR and periodic report submissions to authorities with expert-level proficiency
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Manage portal/gateway setup and product registration processes
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Coordinate unblinding procedures and aggregate report schedules
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Quality control case reports and listings
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Develop and refine global safety reporting procedures and systems
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Analyze compliance metrics and lead quality improvement initiatives
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Serve as SME in regulatory reporting requirements and represent team in audits
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Mentor junior staff and contribute to strategic project management
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Lead client meetings and support cross-functional coordination for timely submissions
Literature (Search and Review)
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Develop and maintain comprehensive literature search strategies aligned with client parameters
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Process citations, review records, and maintain local journal monitoring
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Perform quality checks on search methodologies and implement thesauri updates
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Screen publications for adverse drug reactions and potential safety signals
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Flag relevant findings for medical review and signal detection
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Resolve literature search issues through stakeholder collaboration
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Stay current with literature review guidelines and support training initiatives
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Monitor literature review activities to be aligned with global pharmacovigilance regulations (e.g., EMA, FDA, ICH) and client-specific requirements.
Affiliate Services
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Serve as primary liaison between global safety operations and local affiliates
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Maintain product information and reporting rules in client systems
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Coordinate safety information exchange between headquarters and country offices
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Ensure local compliance with country-specific pharmacovigilance requirements; Support compliance activities including late case investigations
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Support local health authority interactions and information requests
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Manage translation requirements for safety documents across regions
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Coordinate local literature monitoring programs with affiliate teams
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Support implementation of global safety processes at local level
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Provide training to affiliate staff on pharmacovigilance procedures
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Manage follow-ups and query resolution
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Perform periodic data reconciliation and manage safety communications
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Participate in regular client meetings
Regulatory Intelligence
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Research and maintain drug/device safety reporting regulatory intelligence
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Conduct country requirement reviews and support QC activities
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Liaise with authorities to obtain regulatory updates
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Maintain databases and respond to safety reporting queries
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Support GPIO team operations and client interactions
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Ensure compliance with SLAs and KPIs for internal/external clients
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Provide functional expertise to PV Operations staff
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Support audits and process improvement initiatives
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Serve as SME for stakeholders and mentor new team members
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Stay current with relevant regulations and procedures
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Disseminate timely and actionable intelligence to internal teams and clients through summaries, alerts, and presentations.
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Work closely with cross-functional teams including Regulatory Affairs, Quality Assurance, and Safety Operations to ensure alignment and integration of regulatory changes.
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Maintain a centralized repository of regulatory intelligence and contribute to the development of SOPs, training materials, and best practices.
Regulatory Support
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Manage regulatory applications, submissions, and product lifecycle changes in Safety databases
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Assess regulatory impact for variations and create marketing packages
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Support global regulatory activities across multiple regions (EU, US, Asia, Middle East, Africa)
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Perform data remediation for product portfolios during mergers/acquisitions
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Prepare submission packages and track regulatory documents (RMP, PBRER, HASR, PASS)
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Validate data against SmPC and manage xEVMPD submissions
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Create quality control reports and provide technology support
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Maintain accurate records and perform reconciliation activities
Skills:
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Expert knowledge of drug safety regulations and pharmacovigilance processes
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Strong analytical and problem-solving abilities
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Excellent communication and presentation skills
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Superior organizational and time management capabilities
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Proficiency with pharmacovigilance systems and databases
Knowledge and Experience:
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5+ Years of experience in safety case management and regulatory reporting
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Proficiency with safety databases and data analysis
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Strong knowledge of ICH guidelines and regional requirements
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Demonstrated mentoring abilities and process improvement skills
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Experience in pharmaceutical or healthcare environments
Education:
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Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
