Senior Patient Safety Specialist

Benefits

Additional Information

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 an

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