CrawlJobs Logo

Senior Patient Safety Specialist

parexel.com Logo

Parexel

Location Icon

Location:
Philippines , Manila

Category Icon
Category:
IT - Administration

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Responsibility:

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Requirements:

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

Additional Information:

Job Posted:
February 14, 2026

Work Type:
On-site work
Icon
Parexel - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Patient Safety Specialist

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...
Location
Location
United States; Canada , Remote; Alberta
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
  • Good knowledge of drug safety and the drug development process
  • Good knowledge/understanding of medical terminology
  • Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
  • 3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
  • US Board Certification/board eligibility or regional equivalent for Canada
  • Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
  • Completion of at least basic training in clinical medicine (residency, internship etc.)
  • Demonstrated success in technical proficiency and scientific creativity
  • Good presentation and verbal/written communication skills
Job Responsibility
Job Responsibility
  • Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
  • Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
  • Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
  • as applicable) and liaising with the client, as require
  • Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
  • Review appropriateness of medical content in narrative for medical coherence
  • Assessing seriousness, listedness / expectedness of reported events
  • Providing medical inputs to case processing team
  • Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative
What we offer
What we offer
  • Flexible approach to work that meets your personal needs
  • Work from home
  • Benefits vary by country
  • Investment in your professional and personal development
Read More
Arrow Right

Environmental Research Safety Specialist, Senior

Manage and oversee portions of the Accreditation Environment of Care (TJC), and/...
Location
Location
United States , Charlotte; Winston Salem
Salary
Salary:
44.15 - 66.25 USD / Hour
advocatehealth.com Logo
Advocate Health Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree Environmental Health and Safety
  • Minimum 5 years of experience in related discipline required (safety and/or facilities management that includes experience in emergency management, environmental safety, and life safety)
  • Must have the ability to clearly communicate verbally, in person, and in writing with patients, families/agencies and the health care team
  • Must possess a sense of urgency and make sound decisions
  • Responsible for setting a strong example of safety by working safely and utilizing personal protective equipment (PPE) appropriately
  • Critical thinking and independent decision making and is solution oriented
  • Ability to operate computer and computer software programs
  • This position requires travel, therefore, will be exposed to weather and road conditions
  • Travel to other facilities in a personal vehicle is required
  • Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently throughout the workday
Job Responsibility
Job Responsibility
  • Manage and oversee portions of the Accreditation Environment of Care (TJC), and/or Physical Environment (DNV) Safety programs for multiple Advocate facilities
  • Act as liaison for all chapters (Safety, Security, Hazardous Materials/Waste, Clinical Engineering, Fire Safety and Utilities) within the program
  • Coordinate and chair the Environment of Care or Physical Environment Committee, maintain committee agendas and minutes, communicate safety updates to committee
  • Assists with, Occupational Health and Safety (OSHA), Environmental Compliance (EPA), Construction Safety, and Operations activities to maintain constant readiness for surveys and inspections
  • serves as a safety point of contact during federal, state, local and organizational surveys, and inspections
  • Supports regulatory agency personnel during compliance inspections
  • Interfaces with Advocate Facility Administration and Department Leadership to oversee special projects as directed by Safety Leadership and Facility Administration
  • Presents safety programs, safety updates, and/or training to leadership, physicians, vendors/contractors, and teammates
  • Discuss safety and risk assessment impacts to operational changes that has effect on patient safety, teammate safety, visitor safety, and life safety
  • Initiate and disseminate PCRA (Pre-Construction Risk Assessment), ICRA (Infection Control Risk Assessment) and ILSM (Interim Life Safety Measures) documentation for projects at multiple facilities
What we offer
What we offer
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program
  • Premium pay such as shift, on call, and more based on a teammate's job
  • Incentive pay for select positions
  • Opportunity for annual increases based on performance
  • Fulltime
Read More
Arrow Right

Environmental Research Safety Specialist, Senior

Manage and oversee portions of the Accreditation Environment of Care (TJC), and/...
Location
Location
United States , Charlotte; Winston Salem
Salary
Salary:
44.15 - 66.25 USD / Hour
advocatehealth.com Logo
Advocate Health Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree Environmental Health and Safety
  • Minimum 5 years of experience in related discipline required (safety and/or facilities management that includes experience in emergency management, environmental safety, and life safety)
  • Must have the ability to clearly communicate verbally, in person, and in writing with patients, families/agencies and the health care team
  • Must possess a sense of urgency and make sound decisions
  • Responsible for setting a strong example of safety by working safely and utilizing personal protective equipment (PPE) appropriately
  • Critical thinking and independent decision making and is solution oriented
  • Ability to operate computer and computer software programs
  • This position requires travel, therefore, will be exposed to weather and road conditions
  • Travel to other facilities in a personal vehicle is required
  • Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently throughout the workday
Job Responsibility
Job Responsibility
  • Manage and oversee portions of the Accreditation Environment of Care (TJC), and/or Physical Environment (DNV) Safety programs for multiple Advocate facilities
  • Act as liaison for all chapters (Safety, Security, Hazardous Materials/Waste, Clinical Engineering, Fire Safety and Utilities) within the program
  • Coordinate and chair the Environment of Care or Physical Environment Committee, maintain committee agendas and minutes, communicate safety updates to committee
  • Assists with, Occupational Health and Safety (OSHA), Environmental Compliance (EPA), Construction Safety, and Operations activities to maintain constant readiness for surveys and inspections
  • serves as a safety point of contact during federal, state, local and organizational surveys, and inspections
  • Supports regulatory agency personnel during compliance inspections
  • Interfaces with Advocate Facility Administration and Department Leadership to oversee special projects as directed by Safety Leadership and Facility Administration
  • Presents safety programs, safety updates, and/or training to leadership, physicians, vendors/contractors, and teammates
  • Discuss safety and risk assessment impacts to operational changes that has effect on patient safety, teammate safety, visitor safety, and life safety
  • Initiate and disseminate PCRA (Pre-Construction Risk Assessment), ICRA (Infection Control Risk Assessment) and ILSM (Interim Life Safety Measures) documentation for projects at multiple facilities
What we offer
What we offer
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program
  • Fulltime
Read More
Arrow Right

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...
Location
Location
India
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Sound knowledge of drug safety and the drug development process
  • Knowledge of and ability to interpret and apply global safety regulations
  • Experience in data analysis and evaluation of safety data
  • Good presentation skills
  • Analytical and problem-solving skills
  • Clear understanding of the regulatory submission process
  • Proficient in database/literature searches
  • Excellent interpersonal skills
  • Excellent verbal / written communication skills
  • Excellent organizational and prioritization skills
Job Responsibility
Job Responsibility
  • Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
  • Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
  • Assist in development of project specific safety procedures, workflows and templates
  • Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
  • Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
  • Delegate work as appropriate to Drug Safety Assistants
  • Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
  • Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
  • Mentoring new recruits in the team, if required
  • Archiving the source documents and relevant emails as required
Read More
Arrow Right

Medical Director

A unique opportunity to combine clinical excellence with senior leadership. This...
Location
Location
United Kingdom , Barlborough
Salary
Salary:
90000.00 - 170000.00 GBP / Year
compass-associates.com Logo
Compass Associates
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • GMC-registered Consultant on the Specialist Register
  • Substantial post-registration experience within secondary care
  • Proven clinical leadership experience or a strong ambition to transition into a senior leadership role
  • Ability to balance clinical credibility with strategic and operational leadership
  • Strong governance, patient safety, and quality-improvement knowledge
  • Excellent communication, influencing, and team-working skills
  • A forward-thinking mindset with the confidence to challenge and innovate
Job Responsibility
Job Responsibility
  • Provide visible, inspirational clinical leadership across the hospital
  • Lead governance, quality, patient safety, and regulatory compliance, ensuring care exceeds national standards
  • Maintain an agreed clinical commitment within your specialty
  • Drive continuous improvement, innovation, and new models of care
  • Work closely with the senior leadership team, including Nursing and Clinical Services, to deliver strategic and operational objectives
  • Champion a progressive, inclusive, and high-performing clinical culture
  • Support recruitment, appraisal, development, and engagement of medical staff
  • Act as a senior clinical ambassador with external stakeholders, commissioners, and partner organisations
What we offer
What we offer
  • 25 days annual leave plus Bank Holidays
  • Private pension with employer contributions
  • Dedicated CPD support
  • Flexible working arrangements to fit around other commitments
  • A comprehensive wellbeing and lifestyle benefits package
  • Strong long-term career progression opportunities in a supportive environment
Read More
Arrow Right

Procedures Nursing Manager

We are seeking an experienced Procedures Nursing Manager to lead our minor opera...
Location
Location
United Kingdom , Oxford
Salary
Salary:
Not provided
welbeckhealthpartners.com Logo
Welbeck Health Partners
Expiration Date
August 31, 2026
Flip Icon
Requirements
Requirements
  • Experienced Procedures Nursing Manager
  • Provide excellent clinical and managerial leadership
  • Oversee day-to-day organisation and management of endoscopy and respiratory unit, procedure rooms, Mohs lab services, and patient recovery areas
  • Oversight of clinical practice, resource management, clinician engagement, safe staffing provision, and financial management
  • Ensure compliance with regulatory standards
  • Lead nursing team to deliver evidence-based, compassionate care
  • Foster a culture of compassion and respect
  • Maintain visibility within clinical areas
  • Act as a clinical expert in outpatient setting
  • Ensure clinical staff deliver and evaluate individualised patient care to professional standards
Job Responsibility
Job Responsibility
  • Lead minor operations and endoscopy services
  • Oversee procedure rooms, recovery areas, and specialist units
  • Manage clinical practice, staffing, and resources
  • Ensure highest standards of patient care and regulatory compliance
  • Line manage nursing team
  • Maintain excellence across all services
  • Work Monday–Friday during core hours (9–6pm) with flexibility for extended hours or weekends
  • Provide leadership and ensure high-quality service delivery
  • Remain visible and engaged with staff and stakeholders
  • Collaborate with clinicians, senior leaders, and departments to develop services across multiple specialties including gastroenterology, respiratory, dermatology, urology, and gynaecology
  • Fulltime
Read More
Arrow Right

Consultant Geriatric Medicine Specialist

An exciting opportunity has arisen for a motivated and skilled Consultant Geriat...
Location
Location
United Kingdom
Salary
Salary:
100870.00 - 111441.00 GBP / Year
remediumpartners.com Logo
Remedium Partners
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • MBBS or equivalent medical qualification
  • Membership of a relevant Royal College of Physicians
  • Complete registration with the General Medical Council (GMC) with a licence to practise
  • Entry on the GMC Specialist Register in Geriatrics and General Medicine (or within six months of CCT / CESR eligibility)
  • Completion of recognised training in General Internal Medicine
  • High level of clinical competence in geriatric and general medical care
  • Strong IT and clinical documentation skills
  • Knowledge of current best practices and speciality developments
  • Minimum 1 year of NHS experience
  • Experience teaching and supervising undergraduate and postgraduate trainees
Job Responsibility
Job Responsibility
  • Provide comprehensive inpatient geriatric medical care and specialist management of older patients
  • Deliver a weekly outpatient clinic, with potential progression to rapid-access models
  • Participate in annualised / block-based GIM ward commitments
  • Contribute to the consultant on-call rota in line with agreed job planning
  • Provide timely senior clinical decision-making and escalation support
  • Maintain high standards of patient safety, clinical documentation, and evidence-based practice
  • Provide professional supervision and mentoring of junior medical staff
  • Support multidisciplinary team development and collaborative care delivery
  • Contribute to clinical pathway optimisation and service improvement
  • Participate actively in clinical audit, quality improvement programmes, and governance processes
  • Fulltime
Read More
Arrow Right

Consultant Psychiatrist in General Adult Inpatient Psychiatry

An excellent opportunity has arisen for a highly motivated Consultant Psychiatri...
Location
Location
United Kingdom , Greater London
Salary
Salary:
100870.00 - 111441.00 GBP / Year
remediumpartners.com Logo
Remedium Partners
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Primary medical degree
  • Complete registration with the General Medical Council (GMC) with a licence to practise
  • Inclusion on the GMC Specialist Register in General Adult Psychiatry (or within 6 months of CCT)
  • Section 12(2) approval and Approved Clinician (AC) status
  • Minimum 1 year of NHS experience
  • Significant experience managing acute adult psychiatric inpatients
  • Strong competence in risk assessment, CPA processes, and multidisciplinary working
  • Experience supervising junior medical staff
  • Evidence of audit, quality improvement, and governance participation
  • Strong communication and interpersonal skills
Job Responsibility
Job Responsibility
  • Provide consultant-level clinical care for adult inpatients with complex psychiatric presentations
  • Act as a Responsible Clinician (RC) and Approved Clinician for detained patients under the Mental Health Act
  • Lead patient reviews, ensuring senior medical review within 24 hours of admission and weekly consultant reviews
  • Oversee care planning, risk assessments, and CPA processes
  • Conduct Mental Health Act assessments, tribunal reporting, and managers’ hearings
  • Maintain high standards of clinical documentation and timely communication with families and carers
  • Provide clinical leadership for the inpatient multidisciplinary team alongside nursing leadership
  • Lead daily operational meetings, including bed management, safety huddles, and quality reviews
  • Drive quality improvement initiatives and contribute to service evaluation projects
  • Ensure compliance with governance, safety, and performance standards
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy