Senior Patient Safety Specialist

Key Accountabilities :

General

Maintain expert-level knowledge of safety profiles, labeling, and global regulations

Lead development of project-specific procedures and workflows

Provide technical guidance to junior team members

Prepare for and participate in audits and inspections

Analyze metrics and drive continuous improvement

Collaborate with cross-functional teams on safety deliverables

Identify risks and recommend mitigation strategies

Ensure compliant documentation and archiving

ICSR Processing

Lead project management including safety procedure development and database setup

Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)

Manage case documentation including narratives, reconciliation, and quality control

Generate safety reports, listings, and respond to ad hoc requests

Support quality assurance activities, audits, and file maintenance

Collaborate with Medical Directors and represent team in client/investigator meetings

Delegate tasks appropriately and escalate scope changes to management

Assist with resource planning and 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 with expert-level proficiency

Manage portal/gateway setup and product registration processes

Coordinate unblinding procedures and aggregate report schedules

Quality control case reports and listings

Develop and refine global safety reporting procedures and systems

Analyze compliance metrics and lead quality improvement initiatives

Serve as SME in regulatory reporting requirements and represent team in audits

Mentor junior staff and contribute to strategic project management

Lead client meetings and support cross-functional coordination for timely submissions

Literature (Search and Review)

Develop and maintain comprehensive literature search strategies aligned with client parameters

Process citations, review records, and maintain local journal monitoring

Perform quality checks on search methodologies and implement thesauri updates

Screen publications for adverse drug reactions and potential safety signals

Flag relevant findings for medical review and signal detection

Resolve literature search issues through stakeholder collaboration

Stay current with literature review guidelines and support training initiatives

Monitor literature review activities to be aligned with global pharmacovigilance regulations (e.g., EMA, FDA, ICH) and client-specific requirements.

Affiliate Services

Serve as primary liaison between global safety operations and local affiliates

Maintain product information and reporting rules in client systems

Coordinate safety information exchange between headquarters and country offices

Ensure local compliance with country-specific pharmacovigilance requirements; Support compliance activities including late case investigations

Support local health authority interactions and information requests

Manage translation requirements for safety documents across regions

Coordinate local literature monitoring programs with affiliate teams

Support implementation of global safety processes at local level

Provide training to affiliate staff on pharmacovigilance procedures

Manage follow-ups and query resolution

Perform periodic data reconciliation and manage safety communications

Participate in regular client meetings

Regulatory Intelligence

Research and maintain drug/device safety reporting regulatory intelligence

Conduct country requirement reviews and support QC activities

Liaise with authorities to obtain regulatory updates

Maintain databases and respond to safety reporting queries

Support GPIO team operations and client interactions

Ensure compliance with SLAs and KPIs for internal/external clients

Provide functional expertise to PV Operations staff

Support audits and process improvement initiatives

Serve as SME for stakeholders and mentor new team members

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

Assess regulatory impact for variations and create marketing packages

Support global regulatory activities across multiple regions (EU, US, Asia, Middle East, Africa)

Perform data remediation for product portfolios during mergers/acquisitions

Prepare submission packages and track regulatory documents (RMP, PBRER, HASR, PASS)

Validate data against SmPC and manage xEVMPD submissions

Create quality control reports and provide technology support

Maintain accurate records and perform reconciliation activities

Skills:

Expert knowledge of drug safety regulations and pharmacovigilance processes

Strong analytical and problem-solving abilities

Excellent communication and presentation skills

Superior organizational and time management capabilities

Proficiency with pharmacovigilance systems and databases

Knowledge and Experience :

Proven experience in safety case management and regulatory reporting

Proficiency with safety databases and data analysis

Strong knowledge of ICH guidelines and regional requirements

Demonstrated mentoring abilities and process improvement skills

Experience in pharmaceutical or healthcare environments

Education:

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