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 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