Safety Science Coordinator Ii

3 days 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.
- Data entry of safety data on to 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.
- Support and/or participate in audits and inspections including the preparation, as needed.
- Determine listedness against appropriate label (for Marketed products, if applicable)
- Identifies clinically significant information missing from the reports and ensures its collection; Prepare follow-up correspondence in consultation with the medical staff, as needed.
- Perform any other support activities as assigned - tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.
- Reconciliation of Safety information with; SDEA partners; managing timelines of reconciliation

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, 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

    **Job Overview**: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to...


  • 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...


  • Pune, Maharashtra, India Fortrea Full time

    **Summary of Responsibilities**: - ** Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to**: - ** Maintenance of adverse event tracking systems.**: - ** Set-up and maintenance of project files, and central files for documentation.**: - ** Assist with the reporting of...


  • Navi Mumbai, Maharashtra, India Fortrea Full time

    **Job Overview**: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to...


  • 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, Maharashtra, India Fortrea Full time ₹ 5,00,000 - ₹ 8,00,000 per year

    Job OverviewAssist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the...