Senior Patient Safety Specialist

Key Accountabilities:

General

• 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

ICSR Processing

• 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

Safety Submissions

• 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

Literature (Search and Review)

• 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.

Affiliate Services

• 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

Regulatory Intelligence

• 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.

Regulatory Support

• 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

Skills:

• 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

Knowledge and Experience:

• 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

Education:

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