When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Patient Safety Specialist supports global pharmacovigilance activities across clinical trials and post-marketed projects, contributing to the execution of safety processes with increasing autonomy and expertise. Responsibilities may include case processing management, regulatory submissions or support, literature surveillance, affiliate coordination, and safety intelligence, depending on project needs. The Specialist ensures compliance with international and local regulations, internal procedures, and quality standards, while collaborating cross-functionally and supporting continuous improvement in safety deliverables.
Key Accountabilities:
General
- Maintain knowledge of safety profiles, labeling, and global regulations
- Implementation of project-specific procedures and workflows
- Support compliance with regulatory reporting timelines
- Assist with audit and inspection preparation
- Review metrics and participate in improvement initiatives
- Identify potential risks and report to senior staff
- Follow compliant documentation and archiving procedures
- Participating in training and process optimization
- Collaborate with clients to deliver high-quality work
- Work with team members on safety deliverables
- Mentor new team members as needed
ICSR processing
- Support project management including safety procedure implementation
- Execute ICSR processing workflows and assist with case assessment
- Prepare case documentation including narratives and quality control
- Generate routine safety reports and listings
- Support compliance activities and metrics reporting
- Participate in quality assurance activities and file maintenance
- Support Medical Directors and attend client/investigator meetings as needed
- Complete assigned tasks and report challenges to senior staff
- Assist with 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
- Support portal/gateway setup and product registration processes
- Follow unblinding procedures and aggregate report schedules
- Implement global safety reporting procedures and systems
- Maintain reporting requirements and authority registrations
- Quality control case reports and listings
- Monitor compliance metrics and participate in quality improvement initiatives
- Apply regulatory reporting requirements and participate in audit preparation
- Support senior staff and contribute to project management
- Attend client meetings and coordinate with cross-functional teams for timely submissions
Literature (Search and Review)
- Implement literature search strategies aligned with client parameters
- Process citations, review records, and support local journal monitoring
- Perform quality checks on search results
- Screen publications for adverse drug reactions for ICSRs and potential safety signals
- Identify relevant findings for medical review
- Report literature search issues to senior staff
- Follow literature review guidelines and participate in training
- Review database thesauri updates
- Resolve search issues through collaboration
- Monitor literature review activities to be aligned with global pharmacovigilance regulations (e.g., EMA, FDA, ICH) and client-specific requirements.
Affiliate Services
- Support communication between global safety operations and local affiliates
- Maintain product information and reporting rules in client systems
- Support safety information exchange between headquarters and country offices
- Follow local compliance with country-specific pharmacovigilance requirements
- Assist with local health authority interactions and information requests
- Support translation requirements for safety documents
- Assist with local literature monitoring programs
- Implement global safety processes at local level
- Participate in training on pharmacovigilance procedures
- Execute follow-ups and query resolution
- Perform data reconciliation and support safety communications
Regulatory Intelligence
- Support research on drug/device safety reporting regulatory intelligence
- Assist with country requirement reviews and QC activities
- Support communication with authorities regarding regulatory updates
- Help maintain databases and respond to safety reporting queries
- Support GPIO team operations and client interactions
- Follow SLAs and KPIs for internal/external clients
- Apply functional expertise to PV Operations activities
- Assist with audits and process improvement initiatives
- 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
- Assist with regulatory impact assessments for variations and create marketing packages
- Support global regulatory activities across multiple regions
- Assist with data remediation for product portfolios
- Help prepare submission packages and track regulatory documents
- Validate data against SmPC and support xEVMPD submissions
- Generate quality control reports and provide basic technology support
- Maintain accurate records and perform reconciliation activities
Skills:
- Knowledge of pharmacovigilance or regulatory regulations and pharmacovigilance processes
- Good analytical and problem-solving abilities
- Effective communication skills
- Strong organizational and time management capabilities
- Familiarity with pharmacovigilance or regulatory systems and databases
Knowledge and Experience:
- Experience in safety case management and regulatory reporting
- Basic proficiency with safety databases and data analysis
- Knowledge of ICH guidelines and regional requirements
- Willingness to learn and develop process improvement skills
- Experience in pharmaceutical or healthcare environments preferred
Education:
- Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience