Safety Associate Resume Samples

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E King

Emelia

King

60912 Roslyn Station

Detroit

+1 (555) 281 0442

60912 Roslyn Station

Detroit

Phone

p +1 (555) 281 0442

Experience Experience

Detroit, MI

Safety Associate Specialist

Detroit, MI

Kub LLC

Detroit, MI

Safety Associate Specialist

Develop necessary training programs for safety leaders and service workers
Maintain working relationship with local and regional compliance and regulatory authorities (Local / County Health, etc.)
Develop goals/strategies and measurements for station
Conduct internal work safety and food safety assessments; follow-up with corrective actions resulting from assessments by external agencies
Determine trends and create corrective action programs
Create and/or modify safety policies and programs
Initial point of contact for any safety incident

Los Angeles, CA

Global Workplace Safety Associate Manager

Los Angeles, CA

Metz Group

Los Angeles, CA

Global Workplace Safety Associate Manager

Responsible for the oversight, supervision, and deployment of EMEA GWS operations, programs, processes and systems with a focus on mitigating safety risk to Workday’s physical, people and information assets
Assists in development, implementation and supervision of operational plans, in coordination of the function aligning with GWS objectives
Assists in providing direction and leadership to our EMEA offices in support of the GWS business plan, maintaining close business relationships throughout the region
Partners with business group managers including Development, Network Engineering, Operations, Information Security, Privacy, Ethics & Compliance, People & Purpose, Legal, and Finance
Establishes safety project plans for events. Manages internal and/or external staff engaged in the support of these events, and responsible for the protection of workmates, assets and information
In accordance with GWS strategy, assists in supervising complex safety improvement programs across Workday’s organizations and geographies
Aids and supports Employee Health & Safety (EH&S) Manager by identifying risk of, and recommending solutions to, unsafe working conditions

present

Los Angeles, CA

Senior Associate, Consumer Safety

Los Angeles, CA

Bernhard Group

present

Los Angeles, CA

Senior Associate, Consumer Safety

present

Perform toxicological risk assessments for the products, in accordance with the company Policies and guidelines
Ensure safety and regulatory compliance of raw materials, packaging, and devices globally
Conduct California Prop 65 risk assessments for all products marketed in the USA
Ensure the company is up to date with methods for risk assessment
Provide Safety support to various functions during the all phases of the NPD
In compliance with policies, manage in-vivo and/or in-vitro toxicity studies supporting product registration and safety
Liaise with a range of colleagues from Marketing, Regulatory Affairs and R&D Category teams

Education Education

Bachelor’s Degree in Life Sciences

Seton Hall University

Bachelor’s Degree in Life Sciences

Skills Skills

Certified Protection Professional or Physical Security Professional is desirable
Highly ethical, with demonstrated ability to handle highly confidential and sensitive information
Demonstrated knowledge of analytical risk assessment techniques
Demonstrated significant experience in a complimentary area of expertise including, but not limited to: personnel protection, physical asset protection, technology and electronic security systems, information protection, investigations, business continuity planning, hazardous materials incident response or handling, Incident Command systems, EH&S management systems, process safety, hazard analysis, ISO systems, ergonomics, and human factors engineering
Proven ability to influence, supervise and lead others, to solve complex and sensitive problems, and to work well under pressure
Demonstrated analytical skills necessary for the collation of data and the production of physical security and safety management statistics as applied in a corporate setting
Demonstrated ability to manage projects on a regional scale
Demonstrated technical depth and breadth of knowledge of safety and management concepts
Excellent verbal and written communication skills in English
Significant professional network

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Associate Global Safety, Contract Months Resume Examples & Samples

Perform appropriate follow-ups with reporters, distribute safety related queries
Receive, triage, evaluate and forward received domestic safety information to global safety hub in accordance with company’s standard procedures and regulatory requirements
Assess adverse events reports for expedited reporting to Health Canada and ensure reporting within required timeframes
Track and monitor local regulatory reporting compliance; highlight potential compliance risks to manager
Maintain global safety database and the local archive of safety reports
Maintain awareness of the current product labeling on all Amgen’s products
Liaise with study teams, medical information staff, sales representatives and other stakeholders to handle safety related inquiries and to provide guidance in safety information handling; escalate appropriate questions to manager and/or global safety hub
Training groups external to the Global Safety on safety training

Safety Operation Associate Resume Examples & Samples

Management of individual case safety reports in compliance with regulatory and internal requirements and procedures
Provide advice and support to Country Safety Leads in consumer and pharma sectors in support of operations
Support a pro-active compliance culture and engage in Global Medical Organization (GMO) / Global
Medical Safety (GMS) departmental activities to implement changes that drive the highest levels of quality and compliance in the most effective and efficient manner
Participate and lead regional projects to drive standardization and the highest levels of safety quality and compliance in the region
Contribute to the development of appropriate metrics and dashboards to monitor compliance and provide Individual Role & Responsibilities are subject to adjust base on J&J business requirements or Goals & Objectives
Qualification in Medical/ Health Sciences and/or proven equivalent experience in pharmacovigilance and safety issue management
Experience in the pharmaceutical or healthcare industry
Fluent communication skills in English, any additional language are a plus
Understanding of product vigilance requirements for medicinal, devices and cosmetics
Understanding of process excellence principles.Drug & Product Safety Operations

Associate Director, Medical Safety Physician Resume Examples & Samples

Degree/Advanced degree in clinical medicine or pharmacy, appropriate post-medical degree / specialty accreditation strongly preferred
Drug safety experiences in PV or clinical research or drug development in international pharmaceutical companies at least 5 years
Good problem solving and decision making skill
Strong interpersonal skills, with a demonstrated ability to foster team work
Ability to manage discussions and decision making
Excellent communication, conflict management and negotiation skills
Good English/Chinese communication skill (written and verbal)
Opening, optimistic and easy going personality
Good computer application skills.Drug & Product Safety Science

Safety Associate Resume Examples & Samples

0-2 years of safety experience required
Self-driven and resourceful professional
Proven good planning, organization and prioritization skills
Demonstrated good consultative and influencing skills

Consumer Safety Associate Resume Examples & Samples

Conduct hazard evaluations and health risk assessments for global Home & Hygiene products in accordance with RB policies, guidelines, and statutory requirements
Conduct and ensure products are properly classified and categorised per Regional/Country regulatory requirements, and generate appropriate safety documentation
Produce core Consumer Safety documents in accordance with RB policies and statutory requirements
Conduct California Prop 65 risk assessments for all products marketed in the USA
Prepare, maintain and update Regulatory Safety & Environmental files
Manage appropriate Safety, Exposure, and/or Risk assessments on ingredients, formulas, packaging, and devices
Develop and ensure Precautionary and First Aid language for product labels and packaging that are appropriate and meets statutory requirements
Actively participate and contribute in Safety related issues and concerns
BSc/MSc/PhD or equivalent in Toxicology, Pharmacology, Chemistry, Biochemistry and/or a related science and relevant experience
Experience in conducting safety evaluations for aerosols, fragrances is beneficial
Working knowledge of GHS regulatory requirements for US, EU and/or other regions/countries
Experience with risk assessments, data interpretation, critical assessments, and report evaluation
Experience conducting Proposition 65 risk assessments
Experience with Regulatory Toxicology is beneficial
Word processing, spreadsheet and related computer skills a must
Database management skills desirable
Results-oriented, entrepreneurial and self-motivating
Experience in working in multi-functional and multi-cultural teams

Research Associate, Transportation Safety Resume Examples & Samples

M.S. in the area of mechanical engineering
Extensive experience in the automotive industry, providing engineering and analysis support for vehicle crash testing
Extensive experience using finite element analysis and modeling, specifically using the LS-DYNA codes, the finite element mesh generator BAGGEN, and the PATRAN preprocessor
Extensive experience using MADYMO modeling
Extensive experience with finite element pre- and post-processors such as HyperMesh and Hyperworks
Extensive experience in the data analysis and knowledge in the different public accident databases
A strong working knowledge of Department of Transportation and National Highway Traffic Safety Administration Federal Motor Vehicle Safety Standards and regulations
A strong academic and research background in transportation safety topics
Familiarity with the latest transportation safety research areas, concepts, practices, procedures, and problem-solving techniques; and knowledge in the behavior, failure, and numerical models of automotive materials, such as metals, thermos-plastics and composites
Programming skills for developing computational engineering codes and material constitutive model subroutines
Good verbal and written communication skills, especially with technical reports
Experience in working in a collaborative team environment to develop creative solutions to complex challenges, as well as have the ability to work independently; and
Ability to bring new concepts to mechanical designs

Senior Associate Medical Safety Operations Resume Examples & Samples

Safety database experience
Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety
Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools

Safety Associate Resume Examples & Samples

Minimum Bachelor’s Degree in Occupational Safety and Health or other safety concentration
Knowledge of principles and practices of occupational safety and health and/or industrial hygiene
At least one Safety and Health focused internship or co-op position in a manufacturing environment
Previous experience working in a manufacturing or industrial environment

Associate Manager, Clinical Safety Resume Examples & Samples

Global partnership in Development and Implementation of HVT US Safety Processes according to Regulatory Requirements, EW SOPs and Ethical Obligation
Oversee the collection, processing, and tracking of adverse event reporting for HVT Clinical Studies
Safety Trends analysis and adverse event reports for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements (e.g., expedited USADEs, aggregate reports and other regulatory documents as requested)
Managing and Supporting CEC Process including Clinical safety monitoring, data collection, queries, reconciliation to support safety reviews-
Interaction and Support for CEC, DSMB, EC, Publication Committees and Other
Safety Support for protocol Design; Submissions, Reports, Clinical Summaries, Updates and other
Safety Reporting Expertise for EW Team and Sites
Cross-function Collaboration with CRA Team/Sites/CS/and Clinical Operation
Conducting and Supporting CEC Adjudication Activities and DMC activities as needed
Cross functional cooperation and support for Publication Committee and Scientific Communication
Comprehensive knowledge of medical device regulatory documents/ device accountability/ adverse events reporting including the US Code of Federal Regulations (CFR) 820, EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003
Good cooperation with authors and presenters of scientific content
Substantial computer literacy

Senior Associate Global Safety PMS Resume Examples & Samples

Working knowledge of GPSP, GVP and GCP (as applicable to post-marketing clinical studies)
Working knowledge of statistical analysis
Working knowledge of electronic data capture (EDC) and PMS tracking system, and computer system validation
Proficient in English language (business discussions, reading, and writing)

Senior Associate Global Safety Resume Examples & Samples

Timely & accurate capture, routing, translation and follow up of adverse events reported in the local country(ries) for inclusion in the Global Safety database
Assists with timely submission of all reportable adverse event reports
Assists with distribution of periodic safety reports for local and/or regional needs
Assists in safety screening of local medical literature
Assists intake of product complaints in countries where local safety department is designated to support product quality department with this activity

Clinical Safety & Risk Management Medical Associate Resume Examples & Samples

At least two years of clinical or pharmaceutical industry experience is required
This position requires excellent written and oral communication skills, problem-solving ability, and analytical skills
Proficiency with Microsoft program package (Word, Excel, and PowerPoint) is required

Global Workplace Safety Associate Manager Resume Examples & Samples

Responsible for the oversight, supervision, and deployment of EMEA GWS operations, programs, processes and systems with a focus on mitigating safety risk to Workday’s physical, people and information assets
Assists the leader of GWS in improving overall performance by implementing programs in EMEA and other regional offices as applicable to ensure a safe and secure work place and to emphasize safe work habits
Assists in development, implementation and supervision of operational plans, in coordination of the function aligning with GWS objectives
Assists in providing direction and leadership to our EMEA offices in support of the GWS business plan, maintaining close business relationships throughout the region
Partners with business group managers including Development, Network Engineering, Operations, Information Security, Privacy, Ethics & Compliance, People & Purpose, Legal, and Finance
Establishes safety project plans for events. Manages internal and/or external staff engaged in the support of these events, and responsible for the protection of workmates, assets and information
In accordance with GWS strategy, assists in supervising complex safety improvement programs across Workday’s organizations and geographies
Aids and supports Employee Health & Safety (EH&S) Manager by identifying risk of, and recommending solutions to, unsafe working conditions
Supports compliance with laws, regulations, policy, guidelines and record-keeping requirements across the region, working closely with the EH&S Manager to assess same
Working with the EH&S manager, ensures that training is consistent with country regulatory agencies
Works closely with the entire Workplace team to adhere to internal safety policies and to meet local jurisdictional compliance
Develops and maintains great working relationships with building management, tenants, local emergency responders, law enforcement and other public and private organizations to protect Workday
Supports EMEA building projects and acquisitions by providing safety assessments and aiding Safety Systems Manager by contributing to security systems, lock and key and infrastructure design
Administers the Workday’s lock and key program in the region, ensuring that accurate records are maintained
Assists in investigations of theft, major policy violations, and any threats of violence/sabotage to workmates, property, and or information
Responsible for oversight and management of the outsourced onsite team of safety specialists
Participates in placement interviews and works with contract Safety Specialist service management to develop Safety Specialist post orders and procedures
Identifies security issues requiring policy/procedure implementation and improvement
Prepares drafts of proposed procedures for management consideration. Assists or coordinates implementation of approved procedures
Provides site security systems direction to HQ and applicable field offices
Participates as a Workday Emergency Response & Care (WERC) member
Contributes to financial targets/budgets for the function
Preferred BA/BS degree in business, management, criminal justice or equivalent combination of education, military and security/safety related experience
Proven ability to influence, supervise and lead others, to solve complex and sensitive problems, and to work well under pressure
5 years corporate physical security and safety experience demonstrating increasing levels of responsibility
Demonstrated experience managing physical security and safety issues on a regional scale
Demonstrated significant experience in a complimentary area of expertise including, but not limited to: personnel protection, physical asset protection, technology and electronic security systems, information protection, investigations, business continuity planning, hazardous materials incident response or handling, Incident Command systems, EH&S management systems, process safety, hazard analysis, ISO systems, ergonomics, and human factors engineering
Demonstrated management of people (including through vendor relationships), projects and relationships
Demonstrated analytical skills necessary for the collation of data and the production of physical security and safety management statistics as applied in a corporate setting
Demonstrated ability to manage projects on a regional scale
Demonstrated technical depth and breadth of knowledge of safety and management concepts
Demonstrated knowledge of analytical risk assessment techniques
Demonstrated ability to make sound decisions in stressful situations
Working knowledge and experience using computer applications to include iOS, Word, Excel and PowerPoint
Excellent report writing and analytical skills
Demonstrated experience developing and managing an international multi-vendor/consultant network
Significant professional network
Certified Protection Professional or Physical Security Professional is desirable

Associate Manager, Clinical Safety Resume Examples & Samples

Analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site
Develop and write medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures
Bachelor's degree in biological or Lifesciences field required; Engineering degree preferred
8 years of previous hands-on clinical research and experience in an acute cardiovascular or critical care setting required
Proven successful project management skills
Proven expertise in MS Office Suite, Adobe, ERP software (e.g. JDE), CTMS (Clinical Trial Management System) and Patient Tracking system; ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
Skills including consultative and relationship management skills
Extensive understanding of pre-clinical testing protocols, hospital environments and sterile techniques
Extensive understanding of medical terminology as it relates to clinical safety
Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)
Must be able to work in a team environment, including serving as consultant to management

Safety Policy Associate Manager, Global Resume Examples & Samples

Identify, analyze, and document safety policy risks, issues, legislation and regulatory proposals globally, and work with the team to develop, write-up, and track our responses
Identify and analyze safety policy risks, trends, and issues globally and share learnings with all teams involved in policy mission as part of the safety policy team’s efforts to aid them in strategic planning, analysis, and response to related legislative and regulatory initiatives, the development and implementation of safety related policy programs and the influencing of policymakers
Provide feedback on the potential global impact of our policies, products, and features to ensure safety issues are appropriately considered in their development, and assist with landing of the same among policymakers, thought leaders, advocates, and civil society
Assist in the maintenance and deepening of relationships with NGOs, academic experts, and other stakeholders
Work cross functionally with communications, public policy, marketing, product policy, security ops, engineering and programs to elevate influencer knowledge and understanding of all the work being done to ensure the online safety of our community
Speak at selected major safety events and at online safety related meetings with policymakers as needed to communicate Facebook’s efforts regarding online safety, as well as develop and reinforce Facebook’s reputation as a leader in online safety
Bachelor’s Degree in Policy, Government, International Relations, Sociology, or related field
5+ years of relevant work experience in policy
2+ years of experience in technology and safety policy issues
Understanding of safety, privacy, security and technology policy issues
Understanding of applicable regulatory and self-regulatory regimes
Communication, analytic, organizational and interpersonal skills, as well as proactive work ethic
Previously demonstrated ability to work in a fast-paced environment, juggle many different projects at once, find pragmatic solutions to business issues, provide concise and business-focused advice, and make sound judgments under tight deadlines

Safety Associate Trainee Resume Examples & Samples

To Prioritize and complete the assigned trainings on time
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities
Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager
Ensure to meet the expected productivity and quality standards
Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes
Ability to work as a Team Player, contribute and work towards achieving Team goals
Good working knowledge of Microsoft Office and web-based applications
Self-motivated and flexible
Ability to follow instructions/guidelines, utilize initiative and work independently
Ability to manage competing priorities and deadlines
Willingness and aptitude to learn new skills across Safety service lines
Bachelor's degree in life sciences or related field with up to 6 months experience or equivalent combination of education, training and experience

Senior Associate, Consumer Safety Resume Examples & Samples

Perform toxicological risk assessments for the products, in accordance with the company Policies and guidelines
Prepare, maintain and update Safety documentation in line with the relevant Regional / Country regulatory requirements
Ensure safety and regulatory compliance of raw materials, packaging, and devices globally
Ensure the company is up to date with methods for risk assessment
Provide Safety support to various functions during the all phases of the NPD
In compliance with policies, manage in-vivo and/or in-vitro toxicity studies supporting product registration and safety
Liaise with a range of colleagues from Marketing, Regulatory Affairs and R&D Category teams
Work closely with external partners, contractors and licensees to ensure that product safety issues are properly managed and resolved
Provide Safety input to US Household Category in term of NPD and the management of external issues impacting the Category
Ensure hazard and risk assessments, and risk mitigation information for products are carried out in accordance with RB policies, guidelines and statutory requirements globally
Ensure products are properly categorised per global requirements and guidelines; prepare and maintain appropriate Safety documentation
Monitor, collect and interpret all safety issues and trends that will impact RB product, policies and procedures and develop strategies and plans of action to address them. Share this information with the various functions in local and regional businesses, Global Regulatory Affairs and Global Category Development Organisations
Represent RB interests in the area of product safety and product stewardship with government agencies, industry associations and other organisations as directed
As necessary, and in compliance with RB policies, manage all toxicology and safety trials or tests required to support product registration and safety or to substantiate claims
Manage statutory reporting requirements and assist in the response to adverse health effects complaints
Working across different categories globally and keeping abreast of product regulatory requirements and PR and ingredient safety issues within all RB product categories
Ability to respond in a timely manner to many and varied product safety issues which impact on both existing products and new product developments
To keep on top of product/chemical safety legislation and changes to regulations impacting RB products and businesses and ensuring that the appropriate people are aware of potential issues and that necessary action is taken
Allocating resources across the project portfolio to achieve agreed project timelines
Facilitating the relationship with Category Development (R&D, Global Marketing), country Marketing, Supply and other functions to ensure the “seamless” building of safety compliance in our project and product portfolio
Managing the conflicting resource demands on NPD/EPD Development, cost saving initiatives and new technology projects

Safety Associate Manager Resume Examples & Samples

Implement, execute, ensure compliance with the Frito-Lay Inc. North American Foods EHS policies and procedures, and all federal, state, and local OSHA/EPA/DOT regulations (i.e. Lockout, Haz Com, Machine Safety, SARA, RCRA, etc.)
Serves as single point of contact for assigned sites for critical incident management and regulatory agency audits/inspections
Lead the development and implementation of the EHS Action Plans for the region
Achieve annual targets rates for Lost Time, Recordable, Severity, and Environmental
Support site safety audits / assessments / inspections for assigned sites to ensure compliance with regulations and company EHS programs
Develop, implement, execute, and manage strategies to prevent workplace injuries, environmental incidents, and vehicle accidents
Demonstrate solid employee relations experience, interpersonal and verbal/written communication skills
Display strong problem solving, organizational and analytical skills
Demonstrate professional maturity and ability to act as a change leader by influencing all levels of the organization to drive continuous improvement in safety performance
Supports and facilitates training, root causation analysis, incident investigation and regulatory advisement to internal customers within assigned sites
Perform risk assessments and assist in the implementation of effective physical and/ or behavioral control measures and corrective action solutions for assigned sites. Recognize and verify the effectiveness of in-place control measures
Identify unsafe equipment operation and conditions while demonstrating knowledge of appropriate corrective action for unsafe conditions or equipment use
Exercise a leadership, coordination, and communication role with the location leadership to drive continuous EHS improvement across the location
Complete root cause analyses and develop corrective action plans to address root basic causes and management system weak-spots through the use of industry-recognized cause analysis techniques (5-Why, 8-D, etc.)
Lead all OSHA VPP initiatives. Work with OSHA, PepsiCo management, and union employees to effectively manage the program at the site level
Prepare training material and conduct EHS education programs for assigned sites
Bachelor's Degree with greater than 5 years' work experience in EHS
Effective communication and interpersonal skills including public speaking skills and presence in meetings and training environments
Make and deliver training presentations
Work collaboratively with colleagues to create a results driven, team oriented environment
Make independent decisions
Demonstrate excellent organizational skills
Use PC and related software (Microsoft Word, Excel, PowerPoint, Outlook)
Handle multiple priorities and meet critical deadlines
Environmental or Safety management experience in a related industry, including consumer packaged goods, distribution/transportation, manufacturing or grocery industry
Environmental or Safety degree and/or related certification
Knowledge and experience with EHS Management systems and their deployment
EHS auditing
CSP, CIH, and/or CHMM desirable

Safety Data Associate Resume Examples & Samples

Support the Safety project teams
Interact with the Safety Data Managers/Safety Scientists
Be aware of and maintain the workflow and timelines for each project
Enter data into safety database with accuracy
Ensure filing of all documents and organize all filing systems
Interact with staff, clients or partners to ensure case information is adequate and accurate
Perform quality control on entered cases to ensure cases meet highest standards
Participate in and contribute to team meetings
Other duties assigned by management
Good knowledge of pharmacovigilance concepts and definitions
Excellent organizational skills with strong attention to detail
Demonstrated ability to work within deadlines
Self motivated and proactive
Ability to work independently and within a team setting
Fluent in English; additional languages a plus
Scientific knowledge preferred, but not mandatory
Clinical Research experience preferred, but not mandatory

Associate Specialist, Clinical Safety Resume Examples & Samples

Review of adverse event (AE) notifications, CRF (Case Report Forms) and source documents received from the investigational sites to ensure completeness and the need for medical records
Prepare Sponsor Review forms for Medical Safety Officer review
Report complaints from clinical studies to Complaint Handling Group incorporating in accordance with regulatory requirements, trial safety processes and Edwards procedures
Compile and audit patient safety files for accuracy and completeness and to ensure all necessary clinical information and documentation is in place
Prepare source document packets for Clinical Event Committee (CEC) adjudication
Reconcile data and maintain/update in-house safety tracking systems for Safety review, complaint reporting, source documents collection, and adjudication process
In collaboration with Medical Safety Officer and Sr. Specialist, query sites for clarification of clinical data, and work with sites to resolve these queries and discrepancies
Work with the Medical Safety Officer or Sr. Specialist to conduct trend analyses in AE reporting
Educate and provide training to enrolling sites to ensure protocol requirements are followed
Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct
Organize internal or external meetings (such as DSMB or CEC)
Conduct all job duties according to appropriate Standard Operating Procedures (SOPs) and within the context of Good Clinical Practice (GCP) guidelines
Assist other staff as requested and perform other related work, as needed
Bachelor's degree in biological or Lifesciences field required
Minimum of 1 year of clinical research related experience within medical device industry or hospital setting
Understanding of medical terminology as it relates to clinical safety and a background in cardiac preferred
Working knowledge and understanding of domestic and international medical device regulatory guidelines relevant to clinical studies
Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)
Ability to manage confidential information with discretion
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

Associate Manager, Medical Safety Monitor Resume Examples & Samples

Conduct medical assessment on adverse event and/or complaints from clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations, conduct complaint assessments, and report adverse events and complaints according to regulatory requirements, trial safety processes and Edwards’ procedures
Prepare or review event narratives for internal review or external review (Clinical Endpoints Committee), as well as for regulatory submissions
Determine whether or not an event requires formal review (CEC adjudication)
An MD (or equivalent medical degree) is required. At least 3 years of industry experience with device/drug safety or more than 3 years of clinical research experience and safety reporting is required
Internal medicine/cardiology/cardiac surgery preferred
Class III Medical Device experience preferred
Ability to communicate and relate well with key opinion leaders and clinical personnel

Associate Safety Manager, EPC Resume Examples & Samples

Actively Participate in all tool install and construction activities, tool safety level sign-offs and project execution to ensure all local and corporate safety requirements are followed
Ensure that each Subcontractor designates a Safety Representative that is properly trained in the OSHA standards and that person is considered by OSHA standards, competent for the Subcontractors scope of work and has the proper authority to correct safety issues and hazards relating to their safety compliance
Stop at once any violation or unsafe practice. Investigate all incidents and generate proper reports. Establish and maintain all required job safety records. Conduct regular safety meetings
Conduct regular (daily) job site and work area inspections. Record, notify and prepare written report of any violations or unsafe practices to Subcontractors for immediate corrective actions
Establishing and implementing proper fire prevention, evacuation and fire control procedures
Assist the Claims Coordinator in the management of claims. Monitor safety inspections of all equipment used on site. Act as liaison between Tesla and appropriate regulatory agencies
Use independent judgment to assess, analyze and implement corrective actions for any environmental health and safety related infractions or issues and drive and develop the improvement processes and procedures to ensure root cause fixes are developed
Be the primary approver of all new gas and chemicals that will be required for construction and start-up. Ensure correct handling procedures are developed and implemented for these new chemicals. May act as coordinator for the site’s Emergency Response Team
Interact with a variety of departments to conduct training related to safety, emergency response and hazardous material handling
Interact with employees and management in the administration of the worker’s compensation program

Safety Associate Specialist Resume Examples & Samples

Create and/or modify safety policies and programs
Develop goals/strategies and measurements for station
Analyze results and benchmark data
Minimize liability exposures
Develop necessary training programs for safety leaders and service workers
Initial point of contact for any safety incident
Participate in all Board of Inquiries for safety incidents
Prepare and distribute results/findings to internal and external customers
Conduct audits and inspections
Draft and distribute monthly safety bulletin
Determine trends and create corrective action programs
Become visible and actively involved in customer safety programs
Minimum of 3-5 years of relevant experience as Safety Manager or assistant in large facilities, maintenance, construction or manufacturing organization
Background must include experience working in the automotive industry, Safety Program responsibility with proven results, and a thorough knowledge of OSHA, applicable safety standards, and workers compensation issues
Strong organization, leadership, time management and team motivation skills are essential for success in this role
Must be comfortable with frequent computer usage and a good working knowledge of all Microsoft Office applications is required
Bachelor’s Degree in Environmental Health, Human Resources, Industrial Engineering, Business or related curriculum or equivalent experience. Certification by recognized professional bodies preferred (Board of Safety Professionals)

Safety Associate Specialist Resume Examples & Samples

Work closely with Aramark Safety & Risk Control, Aramark District Manager, Location General Managers, and Clients to review, implement and enforce Aramark's SAFE Commitment
Assure highest levels of Guest Service and Quality Control for all supported events
Coordinate and Support District Safety Meeting / Committee Structure
Conduct internal work safety and food safety assessments; follow-up with corrective actions resulting from assessments by external agencies
Work as the leader of each supported team to provide high quality guest experience
Ensure the location has the current Aramark safety standards and procedure documentation in place
Verify the implementation and execution of Aramark safety standards and procedures
Effectively manage internal and external corrective action processes to comply with regulatory requirements to identify cause, address problems, restore control, evaluate and monitor processes, modify procedures or improve the overall safety system approach, and prevent recurrences
Bachelor's degree required - Safety & Health, Business Administration, or Public Health Degree Preferred
2+ years of occupational and/ or food safety experience
Certified ServSafe Instructor is preferred or ability to obtain certification within first 6 months of employment
Flexibility to work within a dynamic work environment and a matrix style reporting structure
Computer essentials; Word, Excel, Outlook, PowerPoint
Ability to proactively assess location food and occupational needs, assist in finding solutions to needs in conjunction with operational team
Lifting 50 pounds maximum with frequent lifting and/or carrying objects weighing up to 25 pounds
Previous management/training experience required
Previous occupational, food, and/or culinary experience in a high volume venue or health or regulatory department preferred
Candidate must be willing to work event based hours - including nights, weekends, and holidays as needed

Safety & Facilities Associate Resume Examples & Samples

Development and training of processes related to Environmental, Health and Safety
Updating procedures to ensure 100% compliance for both OSHA, CAL-OSHA, EPA and other regulatory agencies
Negotiate and coordinate facility mechanical and office repairs
Point person for internal ticketing (Employee services) system
Conduct internal audits, assign actions and implement counter measures
Two plus years of previous of EHS experience preferred
Two plus years of facilities management
Knowledge of State and Federal OSHA regulations
Demonstrated effective communication and writing skills
Experience in a manufacturing regulated environment (i.e. FDA and ISO)
Ability to identify product and processes issues, propose improvements and communicate those clearly to Leads, Management, QA and engineering
Process Improvement methodologies, visual management or Danaher Business Systems
Ability to work effectively and efficiently with minimal supervision
Extremely well organized with solid project planning skills
Education List of Education, Certifications, Training
Practical experience in Occupational Safety or Environmental Health and Safety

Safety Process & Records Management Senior Associate Resume Examples & Samples

Manage the Pharmacovigilance System Master File (PSMF)
Manage Medical Dictionary for Regulatory Activities (MedDRA) expectedness and expedited lists
Manage SABR-controlled documents and provide Process Owner Network (PON) support
Support audit and inspection activities as required
Ensure Safety and Benefit Risk Management (SABR) is implementing and adhering to Development Sciences Business Process requirements
Minimum of 3 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences
Knowledge of post-marketing and clinical trial pharmacovigilance regulations
Direct experience with GXP compliance quality systems is preferred