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 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:
• CRA, CRC Pharmacy related background, or more than 1-2 years' PV experience • Experience in safety case management and regulatory reporting preferred • Basic proficiency with safety databases and data analysis • Knowledge of ICH guidelines and regional requirements • Willingness to learn and develop process improvement skills
Education:
• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience