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Safety Science Coordinator I

3 months ago

Bengaluru, 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 conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
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 ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines.
Ensure all incoming Adverse Event (AE)/ Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox.
Assist with processing of the adverse events, including but not limited to:
Data entry of safety data onto adverse event tracking systems.
Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable).
Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed
Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortreaproject personnel, as required within the agreed timelines.
Maintenance of adverse event tracking systems
Assist with peer/quality review of processed reports and support with trends and actions as needed.
Assist in the reconciliation of databases, as applicable.
Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc.as appropriate.
Prepare and support coordination of safety study files for archiving at completion of projects.
Arrange and schedule internal and/or external meetings/teleconferences.
Train and mentor, the PSS Assistants or peers in their day-to-day activities.
Build and maintain good PSS relationships across functional units.
Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans.
Assume responsibility for quality of data processed.
Provide administrative support to PSS personnel.
All other duties as needed or assigned.
Qualifications/Experience (Minimum required):
Non-Degree or 1-2 years of Safety experience or relevant experience
Associate degree or 6 months to 1 year of Safety experience or relevant experience
PharmD with 0-6 months of Safety experience or relevant experience
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance
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.