Patient Safety Specialist / Philippines-Manila

The Patient Safety Specialist supports global pharmacovigilance activities across clinical trials and post-marketed projects, contributing to the execution of safety processes with increasing autonomy and expertise. Responsibilities may include case processing management, regulatory submissions or support, literature surveillance, affiliate coordination, and safety intelligence, depending on project needs. The Specialist ensures compliance with international and local regulations, internal procedures, and quality standards, while collaborating cross-functionally and supporting continuous improvement in safety deliverables.

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