Safety Science Analyst

2+ years

Not Disclosed

Pune

10 March 19, 2025

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, CPC Certified, 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

Job Title: Clinical Safety Associate

Company: Fortrea, a Global Contract Research Organization (CRO)

Location: [Insert Location]

Job Overview:

Fortrea is seeking a Clinical Safety Associate to assist with Clinical Safety and/or Post-Marketing Surveillance (PSS) operations for various products. This includes managing and processing adverse events, which may involve safety data from clinical trials or post-marketing reports. The role ensures that adverse events are processed according to required standards and submitted to clients and regulatory agencies within agreed timelines. This position is key in delivering high-quality service to clients while ensuring compliance with all applicable regulations and safety standards.

Summary of Responsibilities:

Perform case intake and triage of safety information or reports from various sources, including clinical trials and unsolicited reports.
Assist with the processing of adverse events, including:
- Data entry into adverse event tracking systems.
- Writing patient narratives and coding adverse events using MedDRA (for marketed products, if applicable).
- Assisting in listedness assessment against appropriate labels (for marketed products, if applicable).
- Generating queries and collecting missing or discrepant information in collaboration with medical staff, if needed.
Submit expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, and Fortrea project personnel within the required timelines.
Assist in the processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (clients, regulatory authorities, ethics committees, investigators, and Fortrea project personnel).
Support database reconciliation as applicable.
Work within the Quality Management System (QMS), following Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
Maintain supporting files and documentation in line with adverse event reporting requirements across countries.
Assist in the upload and archival of case/study/project documentation as appropriate.
Foster good relationships across functional units within PSS and other departments.
Ensure compliance with regulatory requirements in all operational processes.
Perform all other duties as assigned.

Qualifications (Minimum Required):

Non-Degree or 6 months - 1 year of safety experience* or relevant experience**.
Associate Degree with 0-6 months of safety experience* or relevant experience**.
BS/BA with 0-6 months of safety experience* or relevant experience**.
MS/MA with 0 years of safety experience* or relevant experience**.
PharmD with 0 years of safety experience* or relevant experience**.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Relevant experience includes working in the pharmaceutical, biotechnology, or CRO industry, especially in areas such as Medical Affairs, Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.

Experience (Minimum Required):

Attention to detail and solid communication skills (written and verbal).
Ability to work effectively in a team.
Accurate math and spelling skills with an aptitude for proofreading numerical data.
Knowledge of MS Office applications beneficial.
Ability to operate standard office equipment.

Physical Demands/Work Environment:

Office environment or remote, as applicable.

Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea encourages diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, regardless of race, religion, color, national origin, gender, sexual orientation, age, veteran status, disability, or any other legally protected characteristic.

For more information about how we collect and store your personal data, please see our Privacy Statement.

If you require a reasonable accommodation to complete your job application, pre-employment testing, or to participate in the interview process, please contact: taaccommodationsrequest@fortrea.com.

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Safety Science Analyst

Job Description

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