Safety Science Specialist

Fortrea

3-5 years

Not Disclosed

Bangalore

15 June 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.

The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited 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
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
Ensure case receives appropriate medical review
Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines
Reporting of endpoints to clients, regulatory authorities, ethics committees,
investigators, 3rd party vendor, Partner and Fortrea project personnel, if required, within study specified timelines
Submission of expedited Serious Adverse Event (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
Assist or contribute to Database reconciliation in liaison with Data Management team or clients
Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, includes but not limited too.
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
Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed
Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance
Assist in the generation and maintenance of the PSS metrics
Support preparation for client meetings and liaise with clients where appropriate.
Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable.
Prepare and support coordination of safety study files for archiving at completion of projects
Support Root cause analysis and CAPA plan development for the identified quality issues, as needed
Support and/or participate in audits and inspections including the preparation, as needed
Demonstrate role-specific Core Competencies and company values on a consistent basis
Build and maintain good PSS relationships across functional units
Any other duties as assigned by management.

The above job duties are completed by the staff as applicable, depending on the role they are assigned to.

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. For more information about Fortrea, visit www.fortrea.com.

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.

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