Patient Safety Associate II

The Patient Safety Associate II supports global pharmacovigilance activities across clinical trials and post-marketed projects, executing safety processes under supervision. Responsibilities may include case processing, regulatory submissions, literature surveillance, affiliate coordination, and safety intelligence, depending on project needs. The Associate follows international and local regulations, internal procedures, and quality standards, while working collaboratively within cross-functional teams to deliver safety deliverables.

Key Accountabilities:

General

• Develop knowledge of safety profiles, labeling, and global regulations
• Follow project-specific procedures and workflows
• Support compliance with regulatory reporting timelines
• Assist with audit and inspection preparation as directed
• Review basic metrics and participate in improvement initiatives
• Identify potential issues and report to supervisors
• Follow documentation and archiving procedures
• Participate in training and process implementation
• Support client interactions under supervision
• Work with team members on safety deliverables
• Support new team members as needed

ICSR processing

Monitor incoming reports from various sources (mailboxes, EudraVigilance, literature)

• Follow established safety procedure implementation
• Perform data entry of valid cases into safety databases
• Validate the accuracy of expectedness, causality assessment, and seriousness criteria for reported events, Execute basic ICSR processing workflows under supervision
• Prepare case documentation including narratives
• Ensure MedDRA coding according to standards
• Support generation of routine safety reports and listings
• Initiate translation requests when required. Review source documents for medical consistency and cohesiveness.
• Conduct quality and validation checks to ensure accuracy.
• Request follow-up and perform query management as applicable
• Follow compliance activities and assist with metrics collection
• Participate in quality assurance activities and file maintenance
• Complete assigned tasks and report challenges to supervisors
• Perform periodic reconciliation for safety data as per client requirement
• Ensure accurate completion of all assigned project deliverables in accordance with Parexel standards, and client contractual obligations/scope.
• Handling of other activities related to case processing as requested/assigned by the client, including but not limited to: End of Study Unblinding (EOSU) or study configuration or Line listing activity or performing self-identified or requested case corrections or performing deletion/deactivation requests as per client conventions and guidelines or performing coding and recoding of Study, Protocol ID, Suspect, Product, Concomitant, Treatment or Adverse Event or Other MAH reporting or Safety notification or Patient Oriented Program (POP) or Social Media (SM) related activities (as applicable)

Safety Submissions

• Support ICSR and periodic report submissions to authorities
• Assist with portal/gateway setup and product registration processes
• Follow unblinding procedures and aggregate report schedules
• Follow global safety reporting procedures and systems
• Help maintain reporting requirements and authority registrations
• Perform quality control on case reports and listings
• Monitor basic compliance metrics
• Apply regulatory reporting requirements under supervision
• Support senior staff and assist with project management tasks
• Attend client meetings when required and support cross-functional coordination
• Set up and deploy worldwide reporting to regulatory authorities, CECs, LECs, and investigator sites (electronic and hard copy). 
• Collaborate with internal and external stakeholders to generate, report, and reconcile compliance metrics.
• Lead safety reporting activities with full ownership, ensuring quality, timely submissions, and compliance tracking.
• Deliver assigned project outputs accurately and on time, in alignment with Parexel standards, regulatory requirements, and client agreements.
• Coach and mentor less experienced reporting associates in safety reporting activities and other work as needed.

Literature (Search and Review)

• Follow literature search strategies aligned with client parameters
• Process citations, review records, and assist with local journal monitoring
• Perform basic quality checks on search results
• Screen publications for adverse drug reactions for ICSRs and potential safety signals, forwarding relevant abstracts or articles for final assessment
• Identify potential findings for medical review
• Report literature search issues to supervisors
• Manually upload full-text articles into the client database when required.
• Request full-text articles for abstracts to enable comprehensive evaluation, as needed.
• Conduct periodic reviews of database thesauri updates and implement necessary adjustments to search strategies in a timely manner.
• Follow literature review guidelines and participate in training
• Support database thesauri updates
• Assist with resolving search issues through collaboration

Affiliate Services

• Support communication between global safety operations and local affiliates
• Help 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
• Execute follow-ups and query resolution under supervision
• Assist with data reconciliation and support safety communications
• Attend regular client meetings when required
• Coordinate with local affiliates to support literature screening activities, to ensure alignment with regulatory requirements.
• Support affiliates in search strategy updates and screening best practices when needed.
• Ensure timely communication and data sharing with affiliates.

Regulatory Support

• Support regulatory applications, submissions, and product lifecycle changes in Safety databases
• Assist with basic regulatory impact assessments and 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

Regulatory Intelligence

• Assist with research on drug/device safety reporting regulatory intelligence
• Support country requirement reviews and QC activities
• Assist with communication regarding regulatory updates
• Help maintain databases and respond to basic safety reporting queries
• Support GPIO team operations
• Follow SLAs and KPIs for internal/external clients
• Apply basic functional knowledge to PV Operations activities
• Assist with audits and process improvement initiatives
• Develop knowledge of relevant regulations and procedures
• Assist in functional internal and external team meetings, as required.
• Undertake additional tasks assigned by management, as needed.

Skills:

• Basic knowledge of drug safety regulations and pharmacovigilance processes
• Developing analytical and problem-solving abilities
• Good communication skills
• Organizational and time management capabilities
• Basic familiarity with pharmacovigilance systems and databases
• Computer proficiency with Windows and MS Office applications

Knowledge and Experience:

• 2 Years experience in Pharmacovigilance.
• Basic understanding of safety databases
• Foundational knowledge of ICH guidelines and regional requirements
• Good knowledge of medical terminology
• Willingness to learn and develop process improvement skills
• Experience or interest in pharmaceutical or healthcare environments preferred

Education:

• Degree in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Dentistry etc.) or equivalent qualification/work experience