Safety Science Coordinator II
Location: Bangalore, India
Application Deadline: November 15, 2024
Fortrea, a global leader in clinical research and development, is seeking a qualified
Pharmacovigilance Safety Science Coordinator II to join its team in Bangalore. This role offers a dynamic opportunity to work with a passionate team dedicated to advancing therapeutic solutions worldwide. Candidates with expertise in life sciences, pharmacy, nursing, or a related field are encouraged to apply.
Fortrea Pharmacovigilance Jobs
Fortrea is known for its commitment to scientific rigor, providing clinical, patient access, and technological solutions across 90+ countries. This position not only supports Fortrea’s mission but also plays a vital role in ensuring patient safety and compliance with regulatory standards.
Key Responsibilities:
- 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 o Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting
- Write patient narratives & code adverse events accurately using MedDRA, if applicable to
- Determine lists 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 Fortrea 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- o 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 Fortrea 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 operations comply with governing regulatory requirements and applicable study/project plans, and take responsibility for the quality of data processed.
- Assist in the preparation of client meetings and liaise with clients where appropriate
- Any other duties as assigned by management.
- The staff completes the above job duties as applicable, depending on their role.
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Fortrea Hiring Pharmacovigilance Safety Science Coordinator II in Bangalore[/caption]
Qualifications:
- Educational Background: A degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, or Life Sciences.
- Experience: 2-3 years in pharmacovigilance or a related field.
- Skills: Proficiency in safety databases, medical coding (MedDRA), and regulatory reporting standards.
How to Apply
Applications are open until
November 15, 2024. Interested candidates can apply through Fortrea's career page to join a transformative journey in pharmacovigilance and patient safety.
Apply here
https://pharmastuff.org.in/job/fortrea-safety-science-coordinator-ii-in-bangalore
