About this role
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