Patient Safety Specialist

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