Senior Patient Safety Specialist

**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