Senior Safety Science Specialist

1 month ago

bangalore, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems Review of adverse events for completeness, accuracy and appropriateness for expedited reporting Write patient narratives and code adverse events accurately using MedDRA Determine listedness against appropriate label (for Marketed products, if applicable) Identifies clinically significant information missing from the reports and ensures its collection and follow-up Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines Perform Database reconciliation with Data Management team or sponsor/client as needed Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including but not limited too Maintenance of adverse event tracking systems Set-up and maintenance of project files and central files for documentation Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed Begin participating in signal detection and trend & pattern recognition activities, as appropriate Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc. Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency Participate in Fortrea project team and client meetings, as appropriate Prepare and support coordination of safety study files for archiving at completion of projects Contribute to root cause analysis, including the CAPA plan development & implementation Support Audits and/or inspections preparation Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees Any other duties as assigned by management.

* The above job duties are completed by the staff as applicable, depending on the role they are assigned to.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

  • Senior Safety Consultant

    4 weeks ago

    bangalore, India TeamTech Environment Health and Safety Private Limited Full time

    Hello Everyone, We are seeking a highly experienced & proactive Freelance Senior Safety Consultant to join our team and support our clients in enhancing safety leadership and culture within their organization. The resource will play a pivotal role in providing project leadership, strategy development, and coordination with client management. Key expertise...

  • Senior Safety Consultant

    1 week ago

    Bangalore City, India TeamTech Environment Health and Safety Private Limited Full time

    Hello Everyone,We are seeking a highly experienced & proactive Freelance Senior Safety Consultant to join our team and support our clients in enhancing safety leadership and culture within their organization. The resource will play a pivotal role in providing project leadership, strategy development, and coordination with client management. Key expertise...

  • Escalations Specialist, Trust

    1 month ago

    bangalore, India ADCI - Karnataka Full time

    Prime Video is changing the way people watch movies and TV shows, with millions of titles available on-demand on Kindle, Fire TV, mobile devices, game consoles, Internet-connected TVs, and Blu-ray players. Content Compliance and Quality is an essential component of Prime Video Trust & Safety charter. We are seeking an innovative and analytical Program...

  • Lead Safety Science Specialist

    49 minutes ago

    Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Lead Safety Science Specialist

    2 months ago

    bangalore, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Safety Science Specialist

    2 weeks ago

    Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Safety Science Specialist

    2 weeks ago

    Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Operations and Support Specialist- Safety

    3 weeks ago

    bangalore, India Haleon Full time

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep...

  • Operations and Support Specialist- Safety

    2 weeks ago

    bangalore, India Haleon Full time

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep...

  • Senior Process Safety Consultant Engineer

    1 month ago

    bangalore, India PM Group Full time

    Overview PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-disciplined team of over 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • Senior Process Safety Consultant Engineer

    4 weeks ago

    bangalore, India PM Group Full time

    Overview PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-disciplined team of over 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • Senior Process Safety Consultant Engineer

    2 weeks ago

    bangalore, India PM Group Full time

    Overview PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-disciplined team of over 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • Lead Safety Science Specialist

    2 weeks ago

    Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Lead Safety Science Specialist

    2 weeks ago

    Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Data Science Specialist

    4 weeks ago

    bangalore, India HCLTech Full time

    HCLTech is hiring for Data Science Specialist for Bengaluru and Chennai locationExperience: 4-8 yearsWork Mode: Work From OfficeSkill Requirement:Responsible for managing technology in projects and providing technical guidance or solutions for work completion.Have experience developing data science projects & basic ML in Python, Dash,...

  • Data Science Specialist

    2 weeks ago

    bangalore, India HCLTech Full time

    HCLTech is hiring for Data Science Specialist for Bengaluru and Chennai locationExperience: 4-8 yearsWork Mode: Work From OfficeSkill Requirement:Responsible for managing technology in projects and providing technical guidance or solutions for work completion.Have experience developing data science projects & basic ML in Python, Dash,...

  • Data Science Specialist

    4 weeks ago

    bangalore, India HCLTech Full time

    HCLTech is hiring for Data Science Specialist for Bengaluru and Chennai location Experience: 4-8 years Work Mode: Work From Office Skill Requirement: Responsible for managing technology in projects and providing technical guidance or solutions for work completion. Have experience developing data science projects & basic ML in Python, Dash, Flask. Should...

  • Senior Security Specialist

    7 days ago

    bangalore, India Pinkerton Consulting & Investigations, Inc. Full time

    The Senior Security Specialist provides comprehensive security management support to ensure the security and safety of company assets, associates, information and interests in the defined area as well as provides security consulting and risk management services for company interests notably in all locations. Essential Functions: 1.Represent...

  • Senior Security Specialist

    3 weeks ago

    bangalore, India Pinkerton Full time

    Job Summary: The Senior Security Specialist provides comprehensive security management support to ensure the security and safety of company assets, associates, information and interests in the defined area as well as provides security consulting and risk management services for company interests notably in all locations. Essential Functions: ...

  • Senior Engineer

    1 month ago

    bangalore, India Mercedes-Benz Full time

    Tätigkeitsbereich:Forschung & Entwicklung incl. DesignFachabteilung:Body E/E - Systems & ComponentsGesellschaft:Mercedes-Benz Research and Development India Private LimitedStandort:Mercedes-Benz Research and Development India, BangaloreStartdatum:sofortVeröffentlichungsdatum:..4Stellennummer:MERT2Arbeitszeit:Vollzeit Join usAufgabenFunctional Safety...