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1.0 - 6.0 years
0 - 0 Lacs
gurugram, faridabad, bhiwani
On-site
We are looking for an experienced We would like to hire an electrician to join our team. You will be responsible for installing and repairing complex electrical control, wiring, and lighting systems working from a technical blueprint. To perform in this role you need an electrician degree from a technical college and experience in the field working on simple and complex electrical systems installing, maintaining, and repairing electrical control, wiring, and lighting systems. reading technical diagrams and blueprints. performing general electrical maintenance. inspecting transformers, circuit breakers, and other electrical components. troubleshooting electrical issues using appropriate testing devices. repairing and replacing equipment, electrical wiring, and fixtures. following National Electrical Code state and local building regulations.
Posted 2 days ago
15.0 - 20.0 years
0 Lacs
hyderabad, telangana
On-site
As a Lead - Safety, Health & Environment (SHE) based in Hyderabad, your main responsibility will be to drive safety initiatives, ensure compliance with regulations, and promote environmental sustainability at our site operations. Your leadership is crucial in upholding our commitment to zero accidents and fostering a strong safety culture within the facility. In this role, you will be expected to lead the implementation of safety measures, including conducting Job Safety Analysis (JSA) for high-risk operations, promoting a near-miss reporting culture, and conducting regular safety inspections and toolbox talks to enhance accident prevention awareness. Your goal will be to achieve zero accidents and dangerous occurrences by effectively managing risk and implementing safety practices. Legal compliance and documentation will also be a key aspect of your role. You will need to develop and maintain procedures to ensure compliance with legal requirements from regulatory bodies such as the Pollution Control Board and PESO. Additionally, you will be responsible for maintaining documentation of all legal licenses, agreements, and compliance records, as well as coordinating the timely renewal of licenses with the Corporate Legal Affairs team. Your role will also involve driving the implementation and maintenance of ISO standards for Environmental, Occupational Health & Safety, and Energy Management at the site level. You will manage the Environmental Safety System (ESS) online platform for incident tracking and monitoring, update work permit procedures, and develop Emergency Preparedness and Response plans. Collaboration with cross-functional teams will be necessary to achieve SHE and sustainability objectives at the site level. You will drive initiatives related to energy conservation, renewable energy adoption, water conservation, and waste reduction programs. Additionally, you will be responsible for coordinating with waste treatment and disposal parties for site-generated waste and preparing environmental agreements in coordination with the Corporate Legal team. In terms of performance management and reporting, you will lead monthly Business Unit APEX meetings, investigate incidents, and implement Corrective and Preventive Actions (CAPA) for all incidents. Your goal will be to ensure continuous improvement in site safety standards and practices through effective communication, coordination, and leadership. To qualify for this role, you should have a Bachelor's degree in Engineering, Environmental Science, or a related field, along with 15-20 years of experience in Safety, Health & Environment management. A professional certification in Safety Management (such as NEBOSH or IOSH) and strong knowledge of ISO standards are required. Experience with legal compliance, incident investigation, and team leadership will be beneficial, as well as proficiency in safety management systems. Preferred qualifications include a Master's degree in Occupational Health & Safety or Environmental Management, experience in manufacturing or industrial site operations, knowledge of risk assessment methodologies, emergency response planning, and coordination with legal affairs and external consultants. Your role will be critical in ensuring the safety, health, and environmental sustainability of our site operations in Hyderabad.,
Posted 2 days ago
5.0 - 10.0 years
17 - 19 Lacs
Bengaluru
Work from Office
It s not just about your career or job title It s about who you are and the impact you will make on the world. Because whether it s for each other or our customers, we put People First. When our people come together, we Expand the Possible and continuously look for ways to improve what we create and how we do it. If you are constantly striving to grow, you re in good company. We are revolutionizing the way the world moves for future generations, and we want someone who is ready to move with us. It s not just about your career or job title It s about who you are and the impact you will make on the world. Because whether it s for each other or our customers, we put People First. When our people come together, we Expand the Possible and continuously look for ways to improve what we create and how we do it. If you are constantly striving to grow, you re in good company. We are revolutionizing the way the world moves for future generations, and we want someone who is ready to move with us. Who are we Wabtec Corporation is a leading global provider of equipment, systems, digital solutions, and value-added services for freight and transit rail as well as the mining, marine, and industrial markets. Drawing on nearly four centuries of collective experience across Wabtec, GE Transportation, and Faiveley Transport, the company has grown to become One Wabtec, with unmatched digital expertise, technological innovation, and world-class manufacturing and services, enabling the digital-rail-and-transit ecosystems. Wabtec is focused on performance that drives progress and unlocks our customers potential by delivering innovative and lasting transportation solutions that move and improve the world. We are lifelong learners obsessed with making things better to drive exceptional results. Wabtec has approximately 27K employees in facilities throughout the world. Visit our website to learn more! Who will you be working with Under the Train Performance & Automation group, the LOCOTROL Engineers design and develop new and exciting solutions for a variety train control requirements. Our automated, semi-automated, and remote-control solutions and products are used globally for a wide variety of freight rail transportation customers; hauling everything from raw metallurgical ore to the very car you drove to work this morning. How will you make a difference As a Systems Engineer, you will utilize experience and expertise to develop and execute objectives for self and others, as well as provide technical solutions, through Embedded Software Applications, for a myriad of customer requests. You will have the ability to affect short-term and some long-term business goals on the LOCOTROL Product portfolio. What do we want to know about you A Bachelor s, or higher, Degree from an accredited college or university in an Electrical Engineering or Software Engineering major. Minimum of 5 years of experience with specification generation for Embedded Software Solutions, requirements management tools, and trace system requirements. What will your typical day look like Decompose internal and external customer inputs and develop a backlog of Software(SW) and Hardware(HW) tasks to distribute to teams to work in a pre-defined period. Develop creative solutions/architectures and define/document system requirements for new and existing SW products, via system specifications and technical memorandums. Provide Requirements to a small team of Software and Validation Engineers in support of the Software Development process. The SE will work with Engineering Program Leaders to develop a workable time-constrained schedule. Participate heavily in safety analysis. Provide input into system test and validation activities. Provide technical support to Program Managers, Product Owners and Project Engineers when communicating with customers, providing estimates for proposals, and coordinating technical aspects for requisitions. Provide Electrical Schematics, SW and HW Designs, as well as other technical documentation to internal and external customers. Travel, possibly globally, to support contract obligations, as required. Work closely with the commercial and technology teams to create system configurations differentiated in the market. Leverage cross-functional and cross business resources to maximize technical results. Provide support as a team Leader for activities such as: Software Development, and Validation, field issues and failures investigations, root cause analysis and implementation of corrective actions, lesson learned issues, and design standards updates. Build solid relationships with key customers and suppliers. Desired Characteristics: Ability to develop Failure Modes / Effects Analyses and perform risk assessments. Ability to work in, and lead, a team environment. Strong written and verbal communication skills. Ability to work in a cross-functional, global environment. Experience with DOORs and/or other requirements management and traceability tools. Railroad industry experience. Experience with Locomotive interfaces and HW platforms. Experience with Railroad communications systems. You may also be asked to perform other duties outside of your function or trade, for which adequate training will be provided if necessary. Our job titles may span more than one career level. The actual salary offered to a candidate may be influenced by a variety of factors, such as: training, transferable skills, work experience, education, business needs, market demands, and work location. The base pay range is subject to change and may be modified in the future. [ IF POSITION IS BONUS ELIGIBLE INCLUDE THE FOLLOWING - This role is also eligible for a performance bonus]. More information on offered benefits, which include health, welfare, and retirement, is available at mywabtecbenefits.com . Relocation assistance may be provided if eligibility requirements are met. Wabtec will only employ those who are legally authorized to work in the U.S. for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable) and fitness for duty test (as applicable). Our Commitment to Embrace Diversity: To fulfill that commitment, we rely on a culture of leadership, diversity, and inclusion. We aim to employ the world s brightest minds to help us create a limitless source of ideas and opportunities. We have created a space where everyone is given the opportunity to contribute based on their individual experiences and perspectives and recognize that these differences and diverse perspectives make us better. . Who are we Wabtec Corporation is a leading global provider of equipment, systems, digital solutions, and value-added services for freight and transit rail as well as the mining, marine, and industrial markets. Drawing on nearly four centuries of collective experience across Wabtec, GE Transportation, and Faiveley Transport, the company has grown to become One Wabtec, with unmatched digital expertise, technological innovation, and world-class manufacturing and services, enabling the digital-rail-and-transit ecosystems. Wabtec is focused on performance that drives progress and unlocks our customers potential by delivering innovative and lasting transportation solutions that move and improve the world. We are lifelong learners obsessed with making things better to drive exceptional results. Wabtec has approximately 27K employees in facilities throughout the world. Visit our website to learn more! http://www.WabtecCorp.com Our Commitment to Embrace Diversity: Wabtec is a global company that invests not just in our products, but also our people by embracing diversity and inclusion. We care about our relationships with our employees and take pride in celebrating the variety of experiences, expertise, and backgrounds that bring us together. At Wabtec, we aspire to create a place where we all belong and where diversity is welcomed and appreciated. . .
Posted 3 days ago
0.0 - 4.0 years
2 - 5 Lacs
Jashipur, Vijayawada, Bengaluru
Work from Office
Post: Safety Supervisor & Safety Officer Location: Bangalore, Vijayawada, Jashipur Salary: 18000-40000 CTC Duty Timing: General Shift Accommodation Traveling Available Site: Manufacturing Plant & Industrial Construction Site Required Candidate profile Candidates must have experience of 0-4 Yrs Candidates having qualification of Diploma/Deg in Safety/Adis/Pdis
Posted 3 days ago
2.0 - 5.0 years
8 - 13 Lacs
Chennai
Work from Office
Responsibilities & Key Deliverables Strategic Leadership Define and implement a group-wide functional safety strategy for current and next-gen vehicles. Align safety vision with business goals, product roadmaps, and regulatory compliance requirements. Represent Mahindra in global safety forums, OEM collaborations, and standards committees. Functional Safety Governance Lead ISO 26262 lifecycle implementation across all vehicle programs (EV, ICE, ADAS, Autonomous). Ensure safety-by-design principles are embedded early in the product development lifecycle. Set up and govern safety work products, safety plans, and confirmation measures. Team & Capability Building Build and mentor a cross-functional team of Functional Safety Managers, Safety Engineers, and ASIL specialists. Foster training and skill development in safety tools (Medini, Ansys, IQ-Forge, etc. ) and methodologies. Collaborate with departments like ADAS, E&E, Powertrain, Body Electronics, and Digital Cockpit. Process & Compliance Oversee functional safety audits, gap assessments, and safety case reviews. Interface with certification agencies (T V, UL, etc. ) to drive compliance and homologation. Ensure integration of SEooC, ASIL decomposition, and HW/SW safety analysis. Program & Product Integration Ensure consistent safety implementation in electronic control units (ECUs), vehicle architecture, and in-vehicle software. Support FMEA, FTA, DFA, FMEDA, and diagnostics activities across development stages. Drive cross-functional reviews with platform leaders, domain heads, and suppliers. Experience 15+ years of experience in Automotive E/E system development, with at least 8 years in Functional Safety leadership. Strong exposure to ADAS, EV platforms, SDV architecture, and safety toolchains. Experience managing end-to-end safety lifecycle in vehicle programs from concept to SOP. Industry Preferred Qualifications Bachelor s/Master s degree in Electronics / Electrical / Automotive Engineering or related field. Certification in ISO 26262 Functional Safety Engineering is highly desirable. General Requirements Deep understanding of ISO 26262, ASPICE, and SOTIF (ISO 21448). Leadership in cross-cultural teams, supplier management, and safety planning. Excellent communication and influencing skills for cross-domain alignment. Familiarity with tools like Medini Analyze, Ansys medini, IQ-Forge, Doors, Polarion, PTC Integrity. Strategic thinking with strong execution focus and decision-making ability.
Posted 4 days ago
3.0 - 5.0 years
3 - 6 Lacs
Navi Mumbai
Work from Office
About The Role Skill required: User-Generated Content Moderation - Content Moderation Designation: Trust & Safety Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years Language - Ability: Japanese - Proficient About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Content moderation is meaningful work that helps keep the internet safe. It may also be challenging, at times. In the context of this role, individuals may be directly or inadvertently exposed to potentially objectionable and sensitive content (e.g., graphic, violent, sexual, or egregious). Therefore, content moderators need strong resilience and coping skills. We care for the health and well-being of our people and provide the support and resources needed to perform their job role responsibilities. Active participation in Accentures well-being support program, designed specifically for the Trust & Safety community, provides valuable skills to promote individual and collective well-being.You will be responsible for analyzing and reviewing user profiles, audio, videos, and text-based content and/or investigating, escalating and/or resolving issues that are reported by users or flagged by the system. Due to the nature of the role, the individual may be exposed to flashing lights or contrasting light and dark patterns.As an Agent, you are responsible toReview content- user profiles, videos, texts, images etcInvestigate and apply client policiesEscalate and/or resolve the issue that is reported by users or flagged by the systemNote- The reported content could be sensitive or of graphic nature What are we looking for The following skills are required to perform this role-Strong coping, emotional resilience, and stress-management skillsAbility to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policiesStrong attention to detailComfort synthesizing and analyzing information from multiple streamsStrong critical thinking and decision-making skillsBasic internet research skillsExcellent comprehension, communication (verbal, written), and JAPANESE skills, required to interpret contentAdditional skills-Be a team player and value cohesivenessBe flexible to cater to changing business needs in a fast-paced environmentBe aware of social trends, political situations, current affairs etc.This is a Work from Office RoleHas Rotational ShiftsMust reside within given boundary limits Roles and Responsibilities: Your role requires following responsibilities Review, classify and/or remove content according to client guidelines, using specific tools and channelsUnderstand and remain updated on changing client policies and guidelinesStay up to date with any changes on policies/processInvestigate, resolve, and relay complex content issues to the broader Trust and Safety teamIdentify improvement opportunities in workflow and suggest solutions to improve quality and overall efficiency of the processParticipate in continuous training programs and workgroup discussions for optimal development in the roleEngage in conversation around socially sensitive topics with the purpose of keeping our communities safeEngage in the well-being activitiesMeet desired efficiency established by business Qualification Any Graduation
Posted 4 days ago
5.0 - 9.0 years
0 Lacs
karnataka
On-site
You will be joining a dynamic team as a Principal Process Engineer with Tecnicas Reunidas group (TR), a leading Oil & Gas International Engineering and Construction Company. As a candidate, you are expected to be organized, motivated, and a proactive team player who takes responsibility for their work. Your primary responsibilities will include analyzing and evaluating existing processes and systems to identify opportunities for improvement in safety, efficiency, and cost-effectiveness. You will develop and implement process optimization strategies to maximize production output while minimizing energy consumption and environmental impact. Conducting feasibility studies, risk assessments, and collaborating with multidisciplinary teams to design and implement process improvements will also be part of your role. Additionally, you will be required to monitor and analyze process data, operational parameters, and performance indicators to identify deviations, troubleshoot issues, and implement corrective actions. Conducting process simulations, developing process documentation, and providing technical support to operations and maintenance teams are essential aspects of this position. To qualify for this role, you should hold a Bachelor's degree in Chemical Engineering, Petroleum Engineering, or a related field, with a master's degree being preferred. Previous experience as a Process Engineer in the oil and gas industry, particularly in upstream or downstream operations, is necessary. Strong knowledge of process engineering principles, process design, optimization, and troubleshooting is required. Familiarity with process simulation software and engineering software would be advantageous. In this role, you will also need effective communication and interpersonal skills to collaborate with multidisciplinary teams and stakeholders. Staying updated with industry trends, technological advancements, and regulatory requirements related to oil and gas production processes is crucial. Participation in safety audits, incident investigations, and compliance assessments to ensure adherence to industry standards and regulatory guidelines is also expected. If you are seeking a challenging opportunity in process engineering within the oil and gas industry and are passionate about sustainable growth, decarbonization, and energy transition, then this role at Tecnicas Reunidas group (TR) might be the right fit for you.,
Posted 6 days ago
4.0 - 7.0 years
9 - 16 Lacs
Kharagpur
Work from Office
Job Title: AM/Manager - Fire & Safety Department: Fire & Safety Location: Kharagpur, West Bengal Reporting To: Head of Department - EHS Experience Required: 4 years Minimum Industry: Steel Manufacturing Company Overview: Jindal Stainless Limited is one of India's largest and most respected stainless steel manufacturers. With a strong emphasis on operational excellence, innovation, and sustainability, we serve diverse sectors ranging from infrastructure and automotive to consumer durables. We are seeking a dynamic and detail-oriented professional to join our Fire & Safety team in the role of ( AM/Manager). Key Responsibilities: The AM/Manager of Fire & Safety will manage and oversee shift operations in CRD, ensuring statutory compliance with safety and fire protection standards while conducting EHS audits, safety inspections, and risk assessments to reduce incidents and promote a strong safety culture. Responsibilities include maintaining and upgrading fire protection facilities, ensuring availability and preventive maintenance of critical safety equipment, and implementing safety systems and PPE management on the shop floor. The incumbent will support documentation, oversee testing of pressure vessels, lifting tools, and critical machines, and update onsite emergency plans regularly. The role includes applying for safety awards, organizing safety promotional events, and fostering continuous improvement through Kaizen initiatives while enhancing team skills through internal and external training programs. The candidate will also develop a thorough understanding of the Occupational Safety, Health, and Working Conditions Code, encourage innovative practices like VR-based training, and collaborate with cross-functional teams for smooth shift operations, vendor and contractor management, and alignment with senior management goals to strengthen the fire and safety systems across the plant. The role will plan and execute safety training programs, toolbox talks, and mock drills, digitize safety data management through portals and maintain accurate documentation for compliance and audit readiness. Qualifications & Experience: B.E. / B.Tech - Fire & Safety RLI & NEBOSH Certifications Key Skills & Competencies: Technical expertise in fire and safety systems, statutory and regulatory compliance, risk assessment and incident investigation, EHS audit skills, safety training and capability building, process improvement mindset, digital data management, stakeholder management, analytical and problem-solving skills, effective communication and reporting, collaboration, integrity, dependability, learning agility, result orientation, and innovation. Why Join Us? At Jindal Stainless, we believe in empowering our people, promoting continuous learning, and providing opportunities to grow within the organization. This role offers high-growth environment within the steel manufacturing sector.
Posted 6 days ago
1.0 - 3.0 years
2 - 4 Lacs
Chennai
Work from Office
Role & responsibilities : Safety Compliance: Adhere to local laws and industry standards for construction site safety. Risk Assessment: Conduct regular inspections to identify hazards and recommend corrective actions. Safety Training: Organize and deliver fire safety, first aid, and emergency response training. Incident Reporting: Record and report safety incidents, near misses, and accidents. PPE Management: Ensure workers are equipped with proper PPE (helmets, gloves, boots, etc.). Site Audits: Perform regular safety audits and ensure compliance with safety measures. Safety Equipment: Oversee installation, maintenance, and functionality of safety equipment (fire extinguishers, alarms, exits). Contractor Coordination: Collaborate with contractors to meet safety standards. Emergency Response: Assist in developing and implementing emergency response plans. Reporting: Prepare and submit safety reports to management for compliance audits. Preferred candidate profile : Degree/Diploma in Civil Engineering or related field; knowledge of safety principles for multi-story buildings preferred. 1-3 years of experience in safety management, especially in high-rise or multi-story building projects. Safety certifications such as NEBOSH, IOSH, or OSHA are a plus. Strong understanding of construction safety regulations, with a focus on multi-story building hazards. Excellent communication skills and ability to work collaboratively with site teams to ensure safety standards are met.
Posted 6 days ago
3.0 - 7.0 years
0 Lacs
shahdol, madhya pradesh
On-site
As an Engineer Mechanical Maintenance, you will be responsible for carrying out maintenance jobs according to preventive maintenance schedules for all equipment at various well sites, Group Gathering Stations, and Compressor stations. Your role will involve identifying potential hazards, participating in Job safety analysis for high-risk activities, conducting toolbox talks, and being a role model for implementing the work permit system for all jobs. It is essential to ensure that processes and utilities are maintained to minimize spurious trips and shutdowns. Collaborating with interdisciplinary engineers will be crucial for the smooth operation of facilities. Additionally, you will assist the maintenance head in budget preparation and cost reduction through optimal resource utilization. Developing interpersonal skills and working self-motivated with minimal supervision are key aspects of this role. Key Skills & Competencies: - Proficiency in industry codes, practices, work permit system, Lockout/Tagout procedures, etc. - Familiarity with operating SAP PM, MM modules. Education Requirement: - Bachelor's degree in Mechanical/Production Engineering. Experience Requirement: - Minimum 3 years of experience in mechanical maintenance within a major oil & gas/Petrochemical/Fertilizer Plant. - Experience in maintaining pumps, reciprocating compressors, motors, gas and diesel-driven generators, valve maintenance, pipeline pigging activities, and utilities. - Knowledge of industry codes, applicable legislation, international standards, and work permit systems is essential for this role.,
Posted 1 week ago
0.0 - 4.0 years
2 - 6 Lacs
Patiala, Pune, Porbandar
Work from Office
Post: Safety Officer Location: Porbandar, Pune, Patiala Salary: 18000-40000 CTC Duty Timing: Depends On Site Accommodation & Travelling Available Site: Industrial revolution Construction Site Required Candidate profile Candidates must have experience of 1-5 Yrs Candidates having qualifications of Dipl/Deg in Safety/NEBOSH/IOSH/ADIS/PDIS if you want more queries then send a mail on: Bdm.saiengineering@gmail.com
Posted 1 week ago
8.0 - 13.0 years
25 - 30 Lacs
Hyderabad
Work from Office
Career Category Research Job Description Job Summary The Global Safety Officer (GSO) for Marketed Products serves 2 roles: 1) safety expert of the assigned marketed product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned marketed products. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Scientists. Key Activities Applicable tasks may vary by product(s) assigned. Product safety profile, benefit-risk evaluation, and risk communication: Accountable for the Development and maintenance of core reference safety information (e.g Core safety information portions of Core Data Sheet [CDS]) Identify relevant data and conduct benefit-risk evaluation Participate in product label process Clinical trial safety: Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing. Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees Perform signal detection activities for developmental products under the direction of the GSO leading the product in development. Signal detection, evaluation, and management: Develop signal detection strategy Evaluate safety signal detection findings, validate signals and determine a need and develop a strategy for further analysis Decide on need for further actions on safety issues and lead cross-functional discussion Documents work as required in the safety information management system Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body Approves the safety assessment report May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Documents work as required in the safety information management system Risk management and minimization: Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document Develop a strategy for safety risk minimization measures globally (including US REMS if applicable) Develop materials for additional risk minimization measures as applicable to role Periodic (aggregate) safety reporting: Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER) Review and approve periodic safety reports Safety Governance Leadership: Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents) Amgen commercialization process: Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Partnerships and integration activities Participate in safety agreement development and review process Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement Perform safety due diligence in preparation for partnerships, etc. Participate in integration activities Other Amgen processes: Interact with external stakeholders (e.g., advisory boards) on safety-related topics Prepare for and participate in regulatory agency advisory committees Provide safety input to support legal needs Managerial and supervisory responsibilities Oversees day to day activities of the Global Safety Physician if applicable Ensure staff are compliant with Amgen corporate and departmental training and SOP review Provide training, coaching, mentoring, and development of staff Assist in the recruitment of talented GPS and AMGEN staff Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes Development plans for staff created annually and reviewed quarterly Education & Experience (Preferred) Medical Degree (MBBS or MD) required from an accredited medical school with atleast 8 years of relevant experience . Product safety in the bio/pharmaceutical industry/CRO or regulatory agency Previous management and/or mentoring experience Clinical/medical research experience .
Posted 1 week ago
3.0 - 5.0 years
2 - 3 Lacs
Devanahalli
Remote
We are seeking a qualified and experienced Safety Engineer to oversee all aspects of health and safety on our railway civil infrastructure project in Bengaluru. The role demands a hands-on safety professional who understands high-risk construction environments, including box pushing, sheet piling, thrust bed excavation, tunneling, and heavy machinery operations under live traffic and viaduct constraints. Role & responsibilities Key Responsibilities : Enforce site safety standards and statutory compliance (BOCW, IS codes, etc.) Conduct daily safety audits, toolbox talks, and safety training Prepare risk assessments, JSAs, and method statements Investigate incidents, maintain safety documentation, and submit reports Coordinate with site teams, contractors, and client safety officers Monitor use of PPE and organize emergency drills
Posted 1 week ago
3.0 - 5.0 years
2 - 3 Lacs
Bengaluru
Work from Office
We are seeking a qualified and experienced Safety Engineer to oversee all aspects of health and safety on our railway civil infrastructure project in Bengaluru. The role demands a hands-on safety professional who understands high-risk construction environments, including box pushing, sheet piling, thrust bed excavation, tunneling, and heavy machinery operations under live traffic and viaduct constraints. Role & responsibilities Key Responsibilities : Enforce site safety standards and statutory compliance (BOCW, IS codes, etc.) Conduct daily safety audits, toolbox talks, and safety training Prepare risk assessments, JSAs, and method statements Investigate incidents, maintain safety documentation, and submit reports Coordinate with site teams, contractors, and client safety officers Monitor use of PPE and organize emergency drills
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
kochi, kerala
On-site
As a MEP Engineer at Kool Home Builders in Kochi, Kerala, you will play a crucial role in the design, development, and testing of electrical equipment and systems, with a primary focus on safety, efficiency, and reliability. Your responsibilities will include analyzing electrical systems and components to identify hazards, defects, or the need for adjustment or repair to ensure compliance with codes. You will be tasked with directing and coordinating construction, installation, maintenance, support, documentation, and testing activities to meet specifications, codes, and customer requirements. Additionally, you will be responsible for performing detailed calculations to establish standards and specifications, utilizing computer-assisted engineering and design software for various engineering tasks. In this role, you will prepare specifications for the purchase of electrical equipment and materials, supervise or train project team members as needed, and estimate material, labor, or construction costs for budget preparation purposes. The ideal candidate should hold a Btech in Electrical Engineering and have a minimum of 3+ years of experience in the construction domain. If you are a proactive and detail-oriented individual with a passion for ensuring the quality and safety of electrical systems, we encourage you to share your resume with us at hr@khbrealty.in. Join our team at Kool Home Builders and enjoy a competitive salary package, with the opportunity to start within less than 20 days.,
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
chennai, tamil nadu
On-site
We are looking for HSE Officers to join one of our projects in China (onshore). In this role, you will be responsible for ensuring that Project/Site HSE plans and procedures are properly implemented during operations. You will report any HSE issues to the Field HSE Manager or site manager and continuously liaise with the workforce and supervision on HSE matters. Your tasks will include conducting internal HSE inspections, delivering HSE induction and training, and supervising the implementation of HSE procedures at the operative sites. It will be your responsibility to ensure the effective implementation of Life Saving Rules and promote safe operative techniques and methodologies for safety control. Additionally, you will be required to inspect subcontractors" activities, control compliance of the equipment used on site, and monitor the implementation of the Permit to Work system. You will also prepare and administer HSE Key Performance Indicators and assist in accident investigations to identify trends and propose corrective measures. To be considered for this position, you must have FPU/FPSO experience, hold a NEBOSH certificate, and have solid experience as an HSE Officer. If you are passionate about ensuring a safe working environment and have the necessary qualifications and experience, we invite you to apply for this challenging and rewarding opportunity.,
Posted 1 week ago
10.0 - 15.0 years
6 - 8 Lacs
Greater Noida
Work from Office
Responsible for Risk Management, Hazards analysis, Fire safety Responsible for training of staff, safety equipment , Accident investigation Coordinating between contractor and management Experience with drills and site emergency plans Required Candidate profile Must know safety norms for High rise-building Projects Knowledge of First aid and safety compliance
Posted 1 week ago
1.0 - 3.0 years
3 - 5 Lacs
Thane
Work from Office
Job Overview Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com
Posted 1 week ago
1.0 - 3.0 years
3 - 5 Lacs
Thane
Work from Office
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate
Posted 1 week ago
3.0 - 4.0 years
5 - 6 Lacs
Thane
Work from Office
Job Overview Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 3 - 4 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com
Posted 1 week ago
4.0 - 6.0 years
6 - 8 Lacs
Thane
Work from Office
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 4 - 6 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate
Posted 1 week ago
3.0 - 5.0 years
2 - 7 Lacs
Dahej, Jamnagar, Mumbai (All Areas)
Work from Office
Post: Safety Supervisor & Safety Officer Location: Mumbai, Jamnagar, Dahej Salary: 22000-45000 CTC Duty Timing: 12 Hrs, 26 Days Accommodation Traveling Available Site: Industrial Construction Site Required Candidate profile Candidates must have experience of 3-5 Yrs Candidates having qualification of Diploma/Deg in Safety If you have any queries please send a mail on: avnetengineers@gmail.com
Posted 1 week ago
15.0 - 20.0 years
45 - 50 Lacs
Bengaluru
Work from Office
Job Title Senior Systems Designer Job Description You are a part of The System Design team of the Systems Engineering department in the Image Guided Therapy (IGT) Systems R&D organization. We are a team of highly skilled people in the system design, system verification, usability and validation and software development domains. We are located in Best, The Netherlands and in Bangalore, India and collaborate with other teams globally. We make sure our products exhibit an excellent user experience and support physicians to provide the best treatment in the most demanding conditions, from cardiovascular to oncological and neurological treatment. We are a solution-based, customer-needs driven organization, working seamlessly across organizations to build the IGT of the future! You are the right fit: Masters degree or equivalent in Engineering 15+ years of relevant experience in designing & developing medical devices / products with demonstrated technical leadership skills Knowledge of IEC standards, risk management, verification and validation of software medical devices Knowhow of design control processes for medical device design. System thinking mindset and domain expertise in the related area. Excellent communication skills Leadership skills and drive for results Experience with Requirements Management tools Experience with Modeling/ Simulation methods & tools Manages complexity and drives results Your role: Managing complexity of products or systems in multi-disciplinary setting, within scope of a single business Leads and influences others and drives design for quality and is closely involved in the program of the applicable business Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance. Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability. Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews. Ensuring full Product Safety Risk Management in a regulation compliant manner. Makes a fundamental contribution to the innovation of products or processes Solves technical problems that have never been encountered previously in the organization. Generates initiatives with regard to technological improvements, and performs future-oriented studies in dialogue with other specialists. Specialist in business and solves complex problems, where responsible for the overall concept at systems level. Draws up design requirements and produces specifications for the product. Draws up schedules, and assigns parts projects to members of staff. Gives them technical guidance. Leading a full product(s) release cycle to ensure quality and compliance Managing complexity of products in a multi-disciplinary and international set-up Lead technically the requirements, design & product specifications for the system / subsystem Monitoring and managing that the requirements and design is implemented correctly by the Agile Release Train Drive design for Quality, Reliability and Serviceability of the system / subsystem Performing safety analysis according to applicable medical device standards Complying to all applicable medical standards / regulations such as CE (EU-MDR) and FDA Support regulatory submissions activities Support project manager on realization, planning and budgets Contributes to future studies, technical concepts and program roadmap Support post market surveillance activities Impact assessment, complaint Investigations and resolution Key Performance Indicators: Product quality: Product Performance (Regulatory) Compliance Product Reliability Technical growth/leadership Stakeholder management On-time delivery to commitments
Posted 2 weeks ago
8.0 - 13.0 years
30 - 35 Lacs
Hyderabad
Work from Office
Career Category Research Job Description Job Summary The Global Safety Officer (GSO) for Marketed Products serves 2 roles: 1) safety expert of the assigned marketed product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned marketed products. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Scientists. Key Activities Applicable tasks may vary by product(s) assigned. Product safety profile, benefit-risk evaluation, and risk communication: Accountable for the Development and maintenance of core reference safety information (e.g Core safety information portions of Core Data Sheet [CDS]) Identify relevant data and conduct benefit-risk evaluation Participate in product label process Clinical trial safety: Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing. Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees Perform signal detection activities for developmental products under the direction of the GSO leading the product in development. Signal detection, evaluation, and management: Develop signal detection strategy Evaluate safety signal detection findings, validate signals and determine a need and develop a strategy for further analysis Decide on need for further actions on safety issues and lead cross-functional discussion Documents work as required in the safety information management system Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body Approves the safety assessment report May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Documents work as required in the safety information management system Risk management and minimization: Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document Develop a strategy for safety risk minimization measures globally (including US REMS if applicable) Develop materials for additional risk minimization measures as applicable to role Periodic (aggregate) safety reporting: Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER) Review and approve periodic safety reports Safety Governance Leadership: Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents) Amgen commercialization process: Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Partnerships and integration activities Participate in safety agreement development and review process Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement Perform safety due diligence in preparation for partnerships, etc. Participate in integration activities Other Amgen processes: Interact with external stakeholders (e.g., advisory boards) on safety-related topics Prepare for and participate in regulatory agency advisory committees Provide safety input to support legal needs Managerial and supervisory responsibilities Oversees day to day activities of the Global Safety Physician if applicable Ensure staff are compliant with Amgen corporate and departmental training and SOP review Provide training, coaching, mentoring, and development of staff Assist in the recruitment of talented GPS and AMGEN staff Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes Development plans for staff created annually and reviewed quarterly Education & Experience (Preferred) Medical Degree (MBBS or MD) required from an accredited medical school with atleast 8 years of relevant experience . Product safety in the bio/pharmaceutical industry/CRO or regulatory agency Previous management and/or mentoring experience Clinical/medical research experience .
Posted 2 weeks ago
0.0 - 3.0 years
2 - 4 Lacs
Mumbai, Chennai, Lanjigarh
Work from Office
Post: Safety Supervisor & Safety Officer Location: Chennai, Mumbai, Odisha Salary: 18000-35000 CTC Duty Timing: Depends on Site Accommodation Travelling Available Site: Industrial Construction Site Required Candidate profile Candidates having experience of 0-3 Yrs Candidates having knowledge about all Fire Safety Instruments For more details email on: HR.magnofiresafety@gmail.com
Posted 2 weeks ago
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