Safety Science Coordinator

3 weeks ago


Pune Maharashtra, 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.

Process the adverse event reports from any source as per client/sponsor agreed plans

 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 & code adverse events accurately using MedDRA, if applicable
- Determine listedness against appropriate label (for Marketed products, if applicable)
- Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed
- Ensure case receives appropriate medical review
- Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines
- Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, if required & as agreed with client during study set-up, within study specified timelines

Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to
- Maintenance of 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 Labcorp project personnel, as required, within study specified timelines

 Support with quality review or peer review of the processed reports

 Assist and/or complete the database reconciliation and the associated activities, as applicable

 Maintain study/project level documentation as per the agreed requirements, as applicable

 Support with training of PSS staff and mentor the team as needed

 Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed)

 Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting and pharmacovigilance

 Assist in the preparation for client meetings and liaise with client contacts, where appropriate

 Assist in Quality issues management and support audit and inspection preparation, as needed

 Ensure compliance of operations with governing regulatory requirements and applicable study/project plans, and take responsibility for quality of data processed

 Assist in the preparation of client meetings and liaise with clients where appropriate

 Any other duties as assigned by management.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

Privacy Statement

.



  • Pune, Maharashtra, 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...


  • Pune, Maharashtra, 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...


  • Pune, India Fortrea Full time

    Description • Receive/identify a suspected ADR/ADE report from, but not limited to, the following sources: directly via mail/ telephone/ fax/ email, Client employee, published literature. • Perform duplicate check, verify & record the following dates, and record in compliance to client requirements. • Acknowledge via e-mail, fax, telephone call...

  • Safety Supervisor

    1 month ago


    Pune, Maharashtra, India House of Speciality Coattings Full time

    3 to 5 years of experience - Site Safety coordination - Worker Safety coordination - Safety equipment coordination - Safety Requirements - Billing Coordination - Well versed with MS Office Tools


  • Pune, India Labcorp Full time

    **Principal Responsibilities** Triage and classify ICSRs for report type, seriousness, causality, labeling and reporting; prioritize ICSR according to regulatory requirements Completion of remaining case data entry, including narrative or auto - narrative Completion of risk and quality (label, approval, and manual coding). Clarification of unclear or...

  • Safety Supervisor

    1 month ago


    Pune, Maharashtra, India Jayka Corp Pvt Ltd Full time

    **Responsibilities**: - Identify potential hazards, risks, and control measures by conducting ongoing reviews of operations and processes. Assess the necessity of implementing these measures to mitigate risks, including evaluating associated costs. - Evaluate and record hazards, risks, and controls according to established procedures and practices. -...


  • Kopar Khairane, Navi Mumbai, Maharashtra, India Universal Fire and Safety Services Ltd. Full time

    1. Perform routine maintenance and inspection of fire alarm systems, including testing of detectors, control panels, and backup power supplies. 2. Conduct regular servicing and troubleshooting of automatic fire suppression systems, such as sprinklers and foam systems. 3. Install, repair, and replace fire safety equipment and components, including fire...

  • Safety Trainer

    1 month ago


    Pune, Maharashtra, India Usha Fire Safety Equipments Pvt Ltd Full time

    **Job description** **Job description** 1) A pivotal role in supporting the effective implementation of various programmers - 1) Excel Communication 1) Experience in program coordination, administrative support, or similar roles. 2) Strong presentation skills, with the ability to engage and captivate audiences during demonstrations. **Job Types**:...

  • Safety Officer

    4 weeks ago


    Pune, Maharashtra, India ONYX Realty Full time

    Safety officers at Construction site **evaluate and monitor health and safety hazards and develop strategies to control risks in the workplace**. They inspect construction sites to ensure compliance with workplace safety regulations and Implement the Company Safety Standards at project site. **Roles and Responsibilities** - Should have sound knowledge of...

  • Safety Officer

    6 days ago


    Deccan, Pune, Maharashtra, India Mittal Brothers Pvt Ltd Full time

    Inspection of project sites, to ensure a hazard-free environment - Assessment and approval of subcontractor safety plans - Verification of tools and equipment to ensure good quality - Promoting safe practices on site - Creating and enforcing safety guidelines and programs - Carrying out drills and exercises on managing emergency situations - Conducting...


  • Pune, Maharashtra, India Saini Electronics Security Systems Full time

    **Role & responsibilities** - To ensure that all personnel at site and the subcontractors appointed follow safe working and comply with the Health, Safety & Environmental plan - To liaise with the Employer Safety Manager / Staff regarding safe work environment required at site. - To ensure that imparting safety induction training and tool box talks are...

  • Safety Officer

    1 month ago


    Undri, Pune, Maharashtra, India Karma Realty Full time

    **Job description** Position: Safety Officer / Safety Officer Supervisor. Position Summary: The role will include 1) Implement the Company Safety Standards at project site. 2) Should have a minimum experience of 2 to 5 years. Role: - Should have sound knowledge of all safety standards as established by the company. - Should monitor and implement all the...

  • Tender Executive

    1 week ago


    Ghansoli, Navi Mumbai, Maharashtra, India Universal Fire and Safety Services Ltd. Full time

    **Key Responsibilities**: - **Tender Identification and Analysis**: - Monitor various tender portals and sources for new tender opportunities. - Analyze tender documents to understand the requirements, specifications, and conditions. - **Tender Preparation**: - Coordinate with various departments (technical, legal, finance, etc.) to gather necessary...

  • Functional Safety

    1 month ago


    Pune, Maharashtra, India Bosch Group Full time

    **Company Description** Bosch Global Software Technologies Private Limited** is a 100% owned subsidiary of Robert Bosch GmbH, one of the world's leading global supplier of technology and services, offering end-to-end Engineering, IT and Business Solutions. With over 22,700 associates, it’s the largest software development center of Bosch, outside Germany,...

  • Safety Officer

    6 days ago


    Pune, India Mittal Brothers Pvt Ltd Full time

    Inspection of project sites, to ensure a hazard-free environment - Assessment and approval of subcontractor safety plans - Verification of tools and equipment to ensure good quality - Promoting safe practices on site - Creating and enforcing safety guidelines and programs - Carrying out drills and exercises on managing emergency situations - Conducting...

  • Safety Supervisor

    6 days ago


    Pune, India Mittal Brothers Pvt Ltd Full time

    Inspection of project sites, to ensure a hazard-free environment - Assessment and approval of subcontractor safety plans - Verification of tools and equipment to ensure good quality - Promoting safe practices on site - Creating and enforcing safety guidelines and programs - Carrying out drills and exercises on managing emergency situations - Conducting...

  • Safety Officer

    4 weeks ago


    Pune, India Karma Realty Full time

    **Job description** Position: Safety Officer / Safety Officer Supervisor. Position Summary: The role will include 1) Implement the Company Safety Standards at project site. 2) Should have a minimum experience of 2 to 5 years. Role: - Should have sound knowledge of all safety standards as established by the company. - Should monitor and implement all the...

  • Safety Officer

    1 month ago


    Nagpur, Maharashtra, India PEB 360 Solutions Full time

    **Key Responsibilities**: 1. **Safety Policy Implementation**: Develop, implement, and enforce safety policies and procedures in compliance with local, state, and federal regulations as well as company standards. 2. **Site Inspections**: Conduct regular inspections of the construction site to identify potential hazards, unsafe conditions, and non-compliance...

  • Safety Steward

    4 weeks ago


    Mumbai, Maharashtra, India Sri Sai overseas recruitments Full time

    **Job description** **1) Training and Education**: - Conduct safety orientations for new workers and provide ongoing training on safety procedures. - Educate personnel on the proper use of personal protective equipment (PPE) and other safety measures. **2) Safety Inspections**: - Perform regular site inspections to identify and rectify safety hazards. -...

  • Safety Steward

    4 weeks ago


    Mumbai, Maharashtra, India Sri Sai overseas recruitments Full time

    **Title - Safety Steward** **Location - Mumbai** **Role - FTC 1 Year Contract** **Salary - 25k - 30K Per Month** **Preferred - Localities** **Domain - Civil/ BMS Background** **Education - Diploma / BE / Equivalent** **Notice - Immediate** **1) Training and Education**: - Conduct safety orientations for new workers and provide ongoing training on...