Safety Science Coordinator
4 weeks ago
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
.
-
Safety Science Coordinator I
5 days ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator I
4 weeks ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator Ii
2 weeks ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator Ii
1 week ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator Ii
4 weeks ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator
2 weeks ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator
2 weeks ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator I
4 weeks ago
Pune, India CSS Fortrea Scientific Pvt Ltd Full timeAs 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 Coordinator I
2 weeks ago
Pune, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeAs 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 Coordinator I
2 weeks ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator II
1 month ago
Pune, India Fortrea Full timeDescription • 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 Science Coordinator II
2 weeks ago
pune, India CSS Fortrea Scientific Pvt Ltd Full timeDescription • 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...
-
Safety Science Coordinator II
2 weeks ago
Pune, Maharashtra, India Fortrea Full timeDescription 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 or mail receipt...
-
Safety Coordinator
5 days ago
Pune, Maharashtra, India Fortrea Full timeAs 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 Coordinator
2 months ago
Pune, India Labcorp Full timeLabcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
-
Safety Science Coordinator
3 months ago
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 Officer
4 weeks ago
Pune, Maharashtra, India Vcatapult recruitment solutions Full time**Position : Safety Officer** **Location : Pune,Maharasdra** **Experience : 1 To 4 Years** **Salary : 15000 To 25000** **Key Responsibilities**: - **Regulatory Compliance**: - Stay informed about local, state, and federal safety regulations and ensure that the organization is in compliance with all applicable standards. - Regularly review and update...
-
Safety Supervisor
3 months ago
Pune, Maharashtra, India House of Speciality Coattings Full time3 to 5 years of experience - Site Safety coordination - Worker Safety coordination - Safety equipment coordination - Safety Requirements - Billing Coordination - Well versed with MS Office Tools
-
Safety Supervisor
4 weeks ago
Pune, Maharashtra, India House of Speciality Coattings Full time3 to 5 years of experience - Site Safety coordination - Worker Safety coordination - Safety equipment coordination - Safety Requirements - Billing Coordination - Well versed with MS Office Tools
-
Clinical Safety Coordinator
4 weeks ago
Navi Mumbai, Maharashtra, India Medpace, Inc. Full timeJob Summary: We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance. If you want an exciting career where you use your previous...
