Drug Safety Associate

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:

• Experience in safety case management and regulatory reporting
• Basic proficiency with safety databases and data analysis
• Knowledge of ICH guidelines and regional requirements
• Willingness to learn and develop process improvement skills
• Experience in pharmaceutical or healthcare environments preferred

Education:

• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience