Data Officer (Local Safety) Job at Product Life Group

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 HSE Officer

Senior HSE Officer will contribute to the development and monitoring process of ...

Location

Greece , Athens

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

BSc or MSc in Engineering (preferable Mechanical or Electrical Engineer)
5+ years of experience in HSE in an industrial/construction environment
Degree relevant to Health & Safety or/and Environmental management
Certification or Training according to ISO 45001 (Lead Auditor) or NEBOSH
Strong understanding of Working at Heights, Permit to Work and LOTO regulations
Good knowledge of Greek HSE legislation & EU directives
Experience as HSE representative according to local regulations (Τεχνικός Ασφαλείας) in industry or construction
Familiar with databases, MS Office & Internet tools
Driving license and ability to visit several Company locations in Greece

Job Responsibility

Oversee implementation of Health & Safety and Environmental Management System
Monitor compliance with ISO 45001, ISO 14001 and other international standards
Provide technical support and guidance to onsite HSE teams
Develop & review HSE procedures, instructions and documentation
Conduct HSE Audits to facilities
Coordinate collection of data and prepare HSE performance reports
Provide technical support in Near Misses, Accidents & Incidents investigation
Monitor Non-Conformities and provide technical support for corrective actions
Monitor & manage external HSE contractors & consultants
Participate in HSE evaluation of Suppliers & Subcontractors

What we offer

Competitive remuneration package
Ticket Restaurant Card
Transportation Allowance
Group Health Insurance program
Discount on the household electricity bill
Pension Plan
Flexible cooperation models

Fulltime

HSE Officer

The HSE Officer will contribute to the development and the monitoring process of...

Location

Greece , Athens

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

BSc or MSc in Engineering
2+ years of experience in HSE in an industrial/construction environment
Degree relevant to Health & Safety or/and Environmental management
Training according to ISO 45001 or relevant
Understanding of HSE regulations with active involvement in reducing/eliminating risk
Experience as HSE representative according to local regulations (Τεχνικός Ασφαλείας) in industry or construction
Familiar with databases and working on & reporting through online platforms, MS Office & Internet tools
Determined and analytical approach to problem solving, non-conformities management and incident investigation
Excellent communication skills, strong team spirit and ability to collaborate with various teams
Driving license and ability to visit several Company locations in Greece

Job Responsibility

Contribute to the implementation of Health & Safety and Environmental Management System for MGM, MECS & MIST according to ISO 45001, ISO 14001
Develop & review HSE documentation (procedures, instructions)
Participate & support HSE Audits to MGM, MECS & MIST
Reporting HSE data from MGM, MECS & MIST facilities on a regular basis (daily, weekly, monthly, yearly)
CSRD Reporting
Monitors the process implementation regarding waste management and other environmental aspects
Collaborate with onsite HSE teams & representatives for everyday HSE issues
Monitor Non-Conformities and/or HSE deviations and provide technical support for the suggestion and evaluation of corrections, corrective & preventive actions
Monitor & manage external HSE contractors & consultants
Perform and promote HSE trainings & campaigns for MGM, MECS & MIST personnel

What we offer

Competitive remuneration package
Ticket Restaurant Card
Transportation Allowance
Group Health Insurance program
Discount on the household electricity bill
Pension Plan
Cooperation, creativity and innovation: flexible cooperation models to achieve fast results and increased productivity

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

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

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
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

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

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Senior Patient Safety Specialist

Location

Philippines , Manila

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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)

Security Training Specialist Senior

Location

United States , Winston Salem

Salary:

35.50 - 53.25 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Certified Law Enforcement Firearms Instructor and Certified Range Safety Officer or obtained within 6 months of hire
Bachelor's Degree in Education or related field
Typically requires 5 years of experience in Instructor/Trainer in private sector security, public safety, law enforcement (local, state, or federal), or the military with at least 1 year experience designing weapons and firearms related content/curriculum and delivering effective training instruction to adult learners
Experience as a firearms instructor (law enforcement and/or military, range safety officer, and firearms armorer
Experience designing content/curriculum and delivering effective training instruction to a variety of audiences, developing viable training plans that result in optimal allocation of limited resources and strong interpersonal skills with the ability to collaborate effectively with multiple/diverse functional areas and multiple business unit leaders and stakeholders
Knowledge and experience with training records management and Microsoft applications (Word, PowerPoint, Excel)
Ability to work a flexible scheduling including off-shifts, weekends, and holiday, as necessary
Ability to work independently and with limited oversight
Extensive experience with scheduling and records keeping including scheduling officers and firearms range locations for initial, remedial and refresher training
Advanced firearms and marksmanship skills strongly preferred

Job Responsibility

Delivers and refines an integrated and multi-modality performance-management training framework for delivery to all Public Safety Officers and security support staff
Uses advanced knowledge of weapons (firearms, batons, handcuffs, and CEW (Taser)) to assist in analysis, design, development, and implementation of programs intended to equip public safety officers for duty
Provide operational oversight and administration of the armed public safety officer program including training program development, records management, public safety officer marksmanship qualification, equipment procurement (i.e., targets, ammunition,) and firearms maintenance (armorer)
Serves as a subject matter expert in physical use of force and weapons (firearms, CEW (Taser), baton, and handcuffing)
Design, develop, implement, and oversee simulated scenario-based training that may include Taser (Axon) virtual reality training, full-scale indoor firearms simulator, and use of force training
Uses program development best practices to design, develop, and implement public safety related training programs across a variety of training delivery platforms- in-person, virtual, computer-based training etc
Responsible for creating and distributing training materials such as manuals, job aids, checklists, response cards, job books, web-based instruction, etc
Works within a specified region to deliver training content
Works with other members of the training team and training manager to develop, refine and deliver training program root-cause analyses, survey data, and site visits to thoroughly understand the operating environment and to identify high payoff opportunities for both locally tailored and system-wide training
Assists in the design and coordination of major training events such as active-shooter and security-related emergency response drills and exercises

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

Senior Manager, Safety Lead, Middle East Autonomous Mobility & Delivery

The Autonomous Mobility and Delivery (AM&D) team at Uber is seeking to accelerat...

Location

United Arab Emirates , Dubai

Salary:

Not provided

Uber

Expiration Date

Until further notice

Requirements

Minimum of 6 years of demonstrated experience in transportation, automotive or autonomous vehicle development
Demonstrated experience with safety standards related to autonomous mobility
Familiarity with functional safety, operational safety, safety management systems, safety cases, safety critical software development, and safety data analysis
Exceptional communication, negotiation, and relationship management skills, with the ability to work across different cultures and industries
Familiarity with the deployment and operations in a transportation environment
Familiarity with or experience contributing to discussions within industry standards organizations (e.g., SAE, AVSC, IEEE, ISO) focused on safety and best practices for autonomous vehicles

Job Responsibility

Regulatory Support and Engagement: Support engagement with local regulators by providing safety insights and technical input on Uber’s AV safety approach and compliance activities
Technical Policy Support: Apply technical understanding of AV safety frameworks to inform and contribute to the development of local safety standards and regulatory guidance
Vehicle and AV Expertise: Develop technical safety recommendations guiding the deployment of AVs (without a safety officer) on the Uber Platform in commercial operations
Fleet Partner Collaboration: Work collaboratively with fleet partners to assure that operational safety requirements are met
Compliance Monitoring: Conduct regular assurance reviews to evaluate ongoing compliance with established safety regulations and standards defined in Uber’s Safety Assurance program
Incident Response: Liaise with various stakeholders to manage and coordinate responses to any safety incidents or concerns
Fleet Partner Safety Enablement: Identify, track, and execute critical partner-related action items to meet safety requirements against operational goals
Industry Awareness: Maintain up-to-date knowledge of safety and health trends in the AV and transportation industries
Cross-functional Leadership: Collaborate with many different skilled individuals across Uber
Standards Collaboration: Contribute to the development of industry safety best practices and standards by collaborating with peers and experts through organizations such as the AVSC, SAE, and other relevant bodies

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Data Officer (Local Safety)

Job Description

Job Responsibility

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