Patient Safety Associate I (Drug Safety Associate I) Job at Parexel

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

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

Patient Safety Associate

Deliver Excellence in Pharmacovigilance. Join Our Patient Safety Team as a Patie...

Location

Australia , Melbourne, Sydney

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Health Science degree or equivalent
Minimum 3 years of experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices
Good working knowledge of the regulatory requirements for managing and reporting adverse events in Philippines
Experience in clinical trial pharmacovigilance
Understanding of the applicable Australia, New Zealand and EU requirements
Highly developed service, communication, organisational and problem-solving skills
High level of attention to detail and computer literacy with experience in safety database (Argus, ARISg, Veeva Safety)
Practical experience in SOP writing and document management

Job Responsibility

Act as part of PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance
Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP)
Ensure that all potential adverse events or product complaints associated with adverse events, are appropriately reported and followed up according to client procedures
Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria
Process & report safety data as per SOP and client instructions to maintain client and regulatory compliance
Maintain the integrity of client safety data registered into the safety databases
Participate in internal and external audits
Perform literature surveillance and regulatory authority adverse event searches
Assist the Project Manager or the Patient Safety Manager/ Senior Manager as requested (e.g. to provide input to SOPs or Safety Data Exchange Agreements)

What we offer

Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
Enjoy a flexible, hybrid work model and commitment to work-life balance
Join a company that values expertise, excellence, collaboration and continuous improvement

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

Manager, Drug Safety Physician, Pharmacovigilance Epidemiology & Risk Management

Location

India , Noida

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree in Medicine
Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety
Strong interpersonal and organizational skills
High sense of responsibility, dedication, and desire to work under pressure
Highly service oriented
Good communication skills
Fluent in English- spoken and written
Previous exposure to corporate environment, pharma and life sciences industry is an advantage
PG degree in any discipline is an advantage but not mandatory

Job Responsibility

Conduct Medical Review and assessment of ICSR’s into the safety database
Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment
Review and respond to any queries/comments from the case owner in the patient safety database
Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers
Maintain strong GPVP and GCP knowledge
Following ICH and EMA guidelines strongly and implementing them appropriately
Train and mentor PV associates on event capturing and general PV conventions as required
Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas
Escalate complex case issues on client products to Team Lead/Line Manager
Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature

Fulltime

Public Safety Officer I - Armed

Registry/PRN - scheduled on-call, as needed, to help fill in for departmental ga...

Location

United States , Park Ridge

Salary:

22.90 - 34.35 USD / Hour

Advocate Aurora Health

Expiration Date

Until further notice

Requirements

Security Officer Healthcare Certification (CHSO) issued by the International Association for Healthcare Security and Safety (IAHSS) must be obtained on a one-time basis within two years of appointment
For North Carolina teammates, an Armed Guard License issued by NC Private Protective Services must be obtained within 1 year and maintained
NIMS Compliance Certification
Firearm Owners Identification (FOID) Card issued by the Illinois State Police OR Concealed Carry Weapon (CCW) license issued by the Department of Justice (DOJ)
Must meet State of IL Department of Financial and Professional Regulation licensing requirements and able to obtain a Firearm Control Card (FCC) for Proprietary Personnel within 90 days of hire
Stop the Bleed Certification must be obtained within 1 year of hire date
A valid driver’s license issued by the Division of Motor Vehicle
Certified in Conducted Energy Weapon (e.g. TASER) use within 90 days of hire and periodically thereafter
Maintains strong awareness of street drugs, gang activity, and human trafficking
High school graduate or GED

Job Responsibility

Provides security services with a customer-service approach, focusing on professionalism, fairness, and compassion even in challenging circumstances and in accordance with policies, procedures, and training
Inspires confidence in patients, visitors, and team members by presenting a professional, approachable, and service-oriented appearance and demeanor
Complies with and enforces all safety and security rules and regulations
Maintains Department uniform and equipment in good repair
Performs routine responsibilities during interior and exterior patrols to ensure safety and security
Assists team members, patients, and visitors by providing information, directions, and physical help
Ensures traffic control, monitors conduct of visitors on premises and confronts unauthorized persons for questioning
Prevents, responds to, and investigates workplace violence
Responds to service calls, such as combative or threatening patients or visitors and team member incidents
Serves as a primary resource for de-escalation, utilizing use of force when necessary

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

Parttime

Public Safety Officer I - Armed

Registry/PRN Status - scheduled on-call, as needed, to help fill in for departme...

Location

United States , Evergreen Park

Salary:

22.90 - 34.35 USD / Hour

Advocate Aurora Health

Expiration Date

Until further notice

Requirements

Security Officer Healthcare Certification (CHSO) issued by the International Association for Healthcare Security and Safety (IAHSS) must be obtained on a one-time basis within two years of appointment
A valid driver’s license issued by the Division of Motor Vehicle
Firearm Owners Identification (FOID) Card issued by the Illinois State Police or Concealed Carry Weapon (CCW) license issued by the Department of Justice (DOJ)
Must meet State of IL Department of Financial and Professional Regulation licensing requirements and able to obtain a Firearm Control Card (FCC) for Proprietary Personnel within 90 days of hire
Certified in Conducted Energy Weapon (Taser) use within 90 days of hire and periodically thereafter
High School Diploma or GED
Typically requires 1 year of experience in a security, related public safety, or customer service area that includes experiences in responding to emergent situations and identifying and resolving issues that pose a potential risk to patients, visitors, staff and/or property
Illinois team members must have completed State of Illinois 40-hour armed course with semi-automatic pistol endorsement
Willingness to carry a department authorized firearm while on duty
Required annually to achieve a passing score of 70% or greater on the State of IL Mandatory Annual Active Duty and Retired Officer Handgun Qualification Course of Fire, un-assisted

Job Responsibility

Provides security services with professionalism, fairness, and compassion in even challenging circumstances and in accordance with policies, procedures, and training
Performs routine responsibilities during interior and exterior patrols to ensure safety and security
Assists team members, patients, and visitors by providing information, directions, and physical help
Ensures traffic control, monitors conduct of visitors on premises, and confronts unauthorized persons for questioning
Prevents, responds to, and investigates workplace violence
Serves as a primary resource for de-escalation
Performs key responsibilities to plan, prevent, practice, and respond to emergencies such as lost or abducted infants/children, fire, and active threats
Responds immediately to emergency and crisis situations
physically intervenes in accordance with training to situations that have a potential for injury
Investigates incidents that occur on Advocate Aurora property and completes timely and accurate reports

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
Opportunity for annual increases based on performance

Parttime

Public Safety Officer I Armed

Public Safety Officer I Armed Full Time position at St Lukes Medical Center. Pro...

Location

United States , Aurora

Salary:

22.90 - 34.35 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Security Officer Healthcare Certification (CHSO) issued by the International Association for Healthcare Security and Safety (IAHSS) must be obtained on a one-time basis within two years of appointment
For North Carolina teammates, an Armed Guard License issued by NC Private Protective Services must be obtained within 1 year and maintained
NIMS Compliance Certification
Firearm Owners Identification (FOID) Card issued by the Illinois State Police or Concealed Carry Weapon (CCW) license issued by the Department of Justice (DOJ)
Must meet State of IL Department of Financial and Professional Regulation licensing requirements and able to obtain a Firearm Control Card (FCC) for Proprietary Personnel within 90 days of hire
Stop the Bleed Certification must be obtained within 1 year of hire date
A valid driver’s license issued by the Division of Motor Vehicle
Certified in Conducted Energy Weapon (e.g. TASER) use within 90 days of hire and periodically thereafter
Maintains strong awareness of street drugs, gang activity, and human trafficking
High school graduate or GED

Job Responsibility

Provides security services with a customer-service approach, focusing on professionalism, fairness, and compassion
Inspires confidence in patients, visitors, and team members by presenting a professional, approachable, and service-oriented appearance and demeanor
Performs routine responsibilities during interior and exterior patrols to ensure safety and security
Assists team members, patients, and visitors by providing information, directions, and physical help
Ensures traffic control, monitors conduct of visitors on premises and confronts unauthorized persons for questioning
Prevents, responds to, and investigates workplace violence
Responds to service calls, such as combative or threatening patients or visitors and team member incidents
Serves as a primary resource for de-escalation, utilizing use of force when necessary
Performs key responsibilities to plan, prevent, practice, and respond to emergencies such as lost or abducted infants/children, fire, and active threats
Responds immediately to emergency and crisis situations

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

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Patient Safety Associate I (Drug Safety Associate I)

Job Description

Job Responsibility

Requirements

Looking for more opportunities?

Patient Safety Associate I (Drug Safety Associate I)

Patient Safety Associate II/Patient Safety Specialist - Japanese

Drug Safety Associate

Patient Safety Associate

Principal Physician, Patient Safety

Manager, Drug Safety Physician, Pharmacovigilance Epidemiology & Risk Management

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