6 Safety Reporting Jobs

Whats the role The SEAM organization integrates Safety, Environment & Asset Management activities, with a broad geographical footprint, that supports Shells business & assets around the world.Technical Asset Services (TAS), which sits in SEAM, is a key enabler for the accelerated delivery of Shell Performance Framework to reach Shells ultimate potential in Chemicals and Products (C+P), Integrated Gas/Renewables and Energy Solutions (IGRES) and Upstream. TAS provides high quality and cost-competitive technical resources who are supporting our Shell sites remotely yet are an integral part of asset teams delivering value through end-to-end AMS work processes. The TAO teams are located across 4 locations: Chennai, Manila, KL & Krakow. Asset Safety Reporting is Part of TAS supporting the Global Safety Reporting process, ensuring top quartile and on-time delivery of the safety reporting data and insights, ensure Process compliance, leveraging where applicable, the group and TAS specific Digitalization journeys. Global digitalization initiatives will include but not be limited to FIM, AMDP, Sphera, Jarvis, HSSE Data & Analytics Platform (DAP), as well as transformation towards application of AI/ML technology to further optimize the digital data diagnostics and integrated reporting process delivery. What you will be doing The purpose of this role is to support safety reporting delivery at Asset level with particular focus on Timely and Quality Safety Performance reporting submissions to Central Reporting Team and Asset LT (monthly, quarterly) and effective QA/QC processes execution. Support for reports with Asset data flowing from Sphera (Incident Data) Delivery of data for External Organizations Complete the OSHA 300 for asset, HWC, RTC and send signed copies to the focal points for the assets. (Regulatory to submit data to OSHA)- Annual Report Complete BSEE0131 and COS data submittals - Annual Reports Complete quarterly reports for JV connects. Annual COS data submission from Power BI, Sphera and other sources Review/remind Action Item owners/responsible parties of their actions - monthly basis Create Sphera "How to" guidance tutorials for as topics that need revising. Improvements and updates to existing dashboards as needed. Incorporate process safety walk and process fundamental KPI data into the HSE dashboard. Support Ops Safety Team with AI deployment & special application projects. Help develop Learnings from Incident apps (Power Apps) to support distribution and visibility of learnings through the organization. Monitoring events in SPHERA and QA/QC checks. Assist with the continuous improvement and implementation of standardized work processes for efficiency in process development and delivery. What you bring Minimum of 4 to 5+ years of experience in an HSSE role Bachelors degree in Engineering or equivalent Certified in NEBOSH IGC or equivalent HSE certification Strong aptitude for Learner Mindset Bird-eye view of HSSE reporting process, AIPSM, PMR, Responsible Care, HSSE & SP CFW and the overlaps of these Skilled in data and reporting systems, e.g., Sphera Cloud, Qlik, DAP, etc. Understanding of the Upstream/DS/IG business and how it works will be beneficial Ability to engage and effectively communicate at all levels inside and outside Shell Proven track record of delivery inAsset and/or Project leadership Experience in project management and facilitating continuous improvement High analytical and problem-solving skills, attention to detail Strong English communication skills - role requires interaction with senior leadership

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publications and represent the company at scientific meetings and conferences Work with the project management team to implement quality and process improvement initiatives Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

Diensten Tech Limited is looking for Medical Safety Physician to join our dynamic team and embark on a rewarding career journey Review adverse event reports and ensure compliance with medical safety regulations Assess drug safety profiles and provide recommendations for risk management Collaborate with regulatory authorities and medical teams for patient safety Analyze clinical data to improve pharmacovigilance and adverse event reporting

Sr Associate Software Engineer - Safety ART - Safety Reporting What you will do Lets do this. Lets change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will engage with business users and functional SMEs, driving the delivery of innovative technology solutions that enhance business outcomes. Areas of focus will be on leading team performance, delivery management, and facilitating continuous improvement in both technical skills and user experience. Roles & Responsibilities: Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs Lead the day-to-day operations and maintenance of Pharmacovigilance (PV) systems. Lead design & development activities and deploy applications to support pharmacovigilance (PV) system. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Provide support and consultation to clients or project teams to identify requirements and assist with application configurations and deployments. Monitor operational and performance statistics for managed systems to ensure reliability and availability. Oversee production change control schedule and participates in change control processes. Maintain knowledge of trends in application development frameworks and related new technologies to provide, recommend, and deliver standard methodology solutions. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 1 - 2 years of experience in Computer Science, Software Development, IT or related field Or Bachelors degree with 2 - 4 years of experience in Computer Science, Software Development, IT or related field Or Diploma with 5 - 8 years of experience in Computer Science, Software Development, IT or related field Functional Skills: Must-Have Skills: Experienced in database programming languages using SQL. Excellent problem-solving and troubleshooting skills. Collaborative spirit and effective communication skills to seamlessly work in a multi-functional team. Hands-on experience with the ITIL framework. Knowledge of SDLC process, including requirements, design, testing, data analysis, change control. Good-to-Have Skills: Experience with API integrations such as MuleSoft, Data Bricks platforms. Experience with programming languages such as Python. Familiarity with cloud technologies such as AWS, Azure. Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Experienced in managing GxP systems and implementing GxP projects. Extensive experience with Software Development Lifecycle (SDLC). Ability to explain technical concepts to non-technical clients. Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and problem-solving skills Excellent leadership and critical thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Ability to deal with ambiguity and prioritize Ability to influence and drive to an intended outcome Ability to hold team members accountable to commitments Shift Information: This individual contributor position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Equal opportunity statement Apply now Apply now

Role & responsibilities Job Title: HSSE Officer Job Location: Krishnapatnam, Nellore ( Terminal - Shift Working) Job type: Permanent REPORTING TO: HSSE Senior Executive Candidate notice period: Immediate joiner only Note: We are looking for candidates from Andhra Pradesh (AP) only Qualifications, Experiences, Knowledge and Skills: 1) Post Graduate Diploma in Safety from a Govt recognized Institute, preferably from Andhra Pradesh. 2) Bachelors degree in safety management or engineering. 3) Experience of 1-2 Years in Safety management, preferably in the LPG or petrochemical industry. 4) Knowledge of relevant Safety standards and regulations, Local DISH regulations, HAZOP, Process Safety, 5) Strong analytical and problem-solving skills. 6) Effective communication and leadership abilities. Languages Telugu, Hindi, English Key Attributes: - Pleasant and able to communicate effectively with individuals at all levels. OVERALL PURPOSE OF THE JOB: - Assist the HSSE Management of the terminal and support Senior HSSE Executive in implementation of the same. Interested candidate please apply here. Also share your profile to chidananda@manpower.co.in; Best Regards, HR Team, Manpower Group Services Preferred candidate profile

Role & responsibilities Job Title: HSSE Officer Job Location: Krishnapatnam, Nellore ( Terminal - Shift Working) Job type: Permanent REPORTING TO: HSSE Senior Executive Candidate notice period: Immediate joiner only Qualifications, Experiences, Knowledge and Skills: 1) Post Graduate Diploma in Safety from a Govt recognized Institute, preferably from Andhra Pradesh. 2) Bachelors degree in safety management or engineering. 3) Experience of 1-2 Years in Safety management, preferably in the LPG or petrochemical industry. 4) Knowledge of relevant Safety standards and regulations, Local DISH regulations, HAZOP, Process Safety, 5) Strong analytical and problem-solving skills. 6) Effective communication and leadership abilities. Languages Telugu, Hindi, English Key Attributes: - Pleasant and able to communicate effectively with individuals at all levels. OVERALL PURPOSE OF THE JOB: - Assist the HSSE Management of the terminal and support Senior HSSE Executive in implementation of the same. Interested candidate please apply here. Also share your profile to chidananda@manpower.co.in; Best Regards, HR Team, Manpower Group Services Preferred candidate profile