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.
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