Patient Safety Associate Job at Product Life Group (Melbourne, Sydney)

Patient Safety Associate I (Drug Safety Associate I)

At Parexel, we’re dedicated to improving patient health worldwide. As a Patient ...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Foundational knowledge of drug safety regulations and pharmacovigilance processes
Ideal candidate has 3+ years experience in Drug Safety
2+ years experience in a post marketing
Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease)
Strong attention to detail, organizational skills, and problem-solving ability
Effective communication and willingness to work in a collaborative team environment
Proficiency with MS Office and ability to learn safety systems/databases
Preference for those with Veeva Safety experience
Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience

Job Responsibility

Processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency
Conducting comprehensive literature searches and reviews to identify safety signals
Supporting signal detection and management activities
Tracking and monitoring regulatory information updates
Assisting in preparing and executing regulatory submissions
Contributing to the development of aggregate reports and study-specific safety documents
Managing Medical and Product Dictionary activities where applicable
Maintaining compliance through quality reviews of safety deliverables
Generating metrics and performance indicators for safety operations
Investigating and documenting late deliverable incidents

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Drug Safety Associate

Drug Safety Associate -Pharmacovigilance Role-Home Based-South Korea-ICON Strate...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

1 year or 1.5 years experience of related experience
Undergraduate degree or its international equivalent, preferably in life science, Nursing, Pharmacy and/or healthcare professional
Advanced knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities

Job Responsibility

Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, patient oriented programs, literature, spontaneous reports, etc
Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality
Manage reporting/submission/distribution of safety reports/updates/information(e.g. SAE, SR, SUSAR, PSUR, DSUR..etc) to local health authorities and/or clinical operations in cooperation with other clinical operation team
Provides technical and process oversight with respect to safety services for larger full service projects or smaller safety stand-alone projects
Ensures quality and consistency across multiple projects for one client
Supports the SRM management team in the development of training courses as well as SOPs and associated documents
Participates in the Safety and Risk Management Regulatory Intelligence activities, to retrieve and maintain a global repository of regulatory safety reporting requirements
개별 사례안전보고서 (수신된 ICSR추적, 회사 또는 고객 안전 DB에 입력, 쿼리 관리)
통합안전보고서 생성지원 (약물별 정기 보고 support)
클라이언트의 라이센스 파트너에게 안전 보고서 제출

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Principal Physician, Patient Safety

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Expertise in drug safety and the drug development process
Demonstrated success in technical proficiency and scientific creativity
Ability to work on complex problems requiring in-depth evaluation
Ability to exercise judgment within broadly defined practices and policies
Good presentation and verbal/written communication skills
Good interpersonal skills
Client focused approach to work
Demonstrated ability to balance technical expert responsibilities with people management duties when assigned
Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps

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
Communicating and discussing issues related to review process with Line Manager/Project Leader/Designee
Interacting with internal and external stakeholders for resolving issues
Attending and/or presenting at client/cross functional meetings along with other stakeholders
Working as Subject Matter Experts (SMEs)
Assisting the Project Lead/Functional Lead for audits and inspections, Act as a Subject Matter Expert during Audits/inspections
Provides inputs for process improvements
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
Function as pharmacovigilance representative/safety scientist

Fulltime

Public Safety Associate

Public Safety Associate (PSA) is a uniform position responsible for providing su...

Location

United States , Milwaukee

Salary:

Not provided

Children's Wisconsin

Expiration Date

Until further notice

Requirements

High School graduate or Certificate of General Educational Development (GED) or High School Equivalency Diploma (HSED) required
1+ years Experience in customer service required
Ability to assess demeanor of internal and external customers, adjusting approach as appropriate to those who could be lost, confused, joyful, upset or demanding with the goal of enhancing the overall experience
Ability to remain calm under pressure to support a safe, welcoming, and therapeutic environment
Ability to successfully complete all required introductory and annual competency training processes to effectively perform duties and responsibilities of position
Basic computer skills in order to utilize and independently troubleshoot and resolve issues with equipment and systems (PC software applications, Microsoft Word, Excel Access, CAD, Incident Reporting, Surveillance Systems, Hospital software applications, EPIC, etc.)
Ability to read and write in order to complete required reports and perform various recordkeeping activities
Critical thinking skills required to make independent decisions and problem solve in a complex, fast paced environment
Excellent customer service and prioritization skills are essential
Exudes confidence and finesse in stressful situations-effectively diffusing negativity

Job Responsibility

Provide badge access credentialing services
actively greet and engage with guests, and visitors to ensure a positive experience
badge and screen visitors according to visitation guidelines
determine the guest's destination and transportation needs, providing assistance as needed
direct visitors with precise way finding
report suspicious activities
provide support and guidance to visitors during emergency conditions
perform Weapon Screening services at designated locations to prevent weapons and other prohibited property from entering Children's property
Primarily works at Welcome Center stations
Badges and screens visitors per our visitation policy

Parttime

Public Safety Associate

Public Safety Associate (PSA) is a uniform position responsible for providing su...

Location

United States , Milwaukee

Salary:

Not provided

Children's Wisconsin

Expiration Date

Until further notice

Requirements

High School graduate or Certificate of General Educational Development (GED) or High School Equivalency Diploma (HSED) required
Post high school coursework in criminal justice or equivalent field of study preferred
1+ years Experience in customer service required
1+ years Experience as a uniformed security officer in healthcare security, public safety, corporate security, law enforcement, and/or military service preferred
1+ years Experience performing weapon screening preferred
BLS-Basic Life Support Healthcare Provider - American Heart Association/American Red Cross/National Safety Council within 90 Days required

Job Responsibility

Provide badge access credentialing services
Actively greet and engage with guests, and visitors to ensure a positive experience
Badge and screen visitors according to visitation guidelines
Determine the guest's destination and transportation needs, providing assistance as needed
Direct visitors with precise way finding
Report suspicious activities
Provide support and guidance to visitors during emergency conditions
Perform Weapon Screening services at designated locations to prevent weapons and other prohibited property from entering Children's property
Build credible relationships with customers by delivering personal attention, demonstrating respect, recognizing patient’s rights under HIPAA and maintaining patient confidentiality
Secure property/evidence as needed/directed

Parttime

Public Safety Associate

Public Safety Associate is a uniform position responsible for providing support ...

Location

United States , Milwaukee

Salary:

Not provided

Children's Wisconsin

Expiration Date

Until further notice

Requirements

Must complete CPR certification – Basic Life Support (BLS) for Healthcare Providers through American Heart Association or American Red Cross within 3 months of hire
A high school diploma or GED
A minimum of one year customer service experience including conflict management situations
Exhibits guiding behaviors that reflect Children’s values and support our mission and vision
Basic computer skills in order to utilize equipment and systems (PC software applications, Microsoft Word, Excel Access, CAD, Incident Reporting, Surveillance Systems, Hospital software applications EPIC, etc.
Ability to read and write in order to complete required reports and perform various recordkeeping activities
Ability to successfully complete department approved Defensive Training for Security (DTS) program
Critical thinking skills required to make independent decisions and problem solve in a complex, fast paced environment
Excellent customer service, communication, interpersonal, and prioritization skills
Ability to work independently or as a team

Job Responsibility

Provide badge access credentialing services
Actively greets and engages with guests, visitors to ensure a positive experience
Badges and screens visitors according to visitation guidelines
Determines the guest’s destination and transportation needs, providing assistance as needed
Directs visitors with precise way finding
Report suspicious activities
Provides support and guidance to visitors during emergency conditions
Performing Weapon Screening services at designated locations to prevent weapons and other prohibited property from entering Children’s property

Parttime

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Patient Safety Associate

Job Description

Job Responsibility

Requirements

What we offer

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