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Safety Science Coordinator Ii

4+ years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Safety Science Coordinator II

Location: Pune
Category: Clinical
Job ID: 25293


About Fortrea

Fortrea is a global contract research organization (CRO) committed to scientific excellence and clinical development. Serving pharmaceutical, biotechnology, and medical device clients, Fortrea offers clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in approximately 100 countries, Fortrea is driving innovation to accelerate the delivery of life-changing therapies to patients worldwide.


Key Responsibilities

Adverse Event Processing

  • Manage the receipt and processing of adverse event reports from various sources, including spontaneous reports and clinical trials.
  • Accurately enter safety data into adverse event databases and tracking systems.
  • Review adverse event reports for completeness, accuracy, and expedited reporting requirements.
  • Write patient narratives and code adverse events using MedDRA, ensuring proper alignment with product labeling.
  • Identify missing clinically significant information in reports and generate queries to collect it, consulting medical staff when necessary.

Expedited Reporting and Case Management

  • Prioritize and process cases requiring expedited reporting to regulatory agencies or other stakeholders within specified timelines.
  • Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and other parties as per study-specific requirements.
  • Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) while maintaining tracking systems and project documentation.

Quality Assurance and Compliance

  • Support quality review or peer review of processed reports.
  • Assist with database reconciliation and maintain study/project documentation.
  • Ensure compliance with Standard Operating Procedures (SOPs), regulatory requirements, and study/project plans.
  • Assist in quality management, audit preparation, and inspection readiness.

Client and Team Support

  • Prepare for client meetings and liaise with client contacts as needed.
  • Provide training and mentorship to PSS staff, supporting team growth and development.
  • Contribute to monthly status reports and maintain PSS metrics when required.

Qualifications

Minimum Requirements

  • Comprehensive understanding of pharmacovigilance procedures, safety management, and regulatory requirements.
  • Proficiency in adverse event database systems, MedDRA coding, and safety reporting processes.
  • Strong organizational and time-management skills.
  • Ability to collaborate within cross-functional teams and liaise effectively with clients.

Preferred Skills

  • Experience in audit preparation, quality review, and compliance monitoring.
  • Strong technical knowledge of safety data processing and reporting tools.
  • Leadership abilities to mentor team members and oversee quality standards.

Why Join Fortrea?

  • Opportunity to work on innovative clinical trials with global impact.
  • A collaborative environment fostering personal and professional growth.
  • Commitment to diversity, equity, and inclusion in the workplace.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer (EOE/AA) committed to fostering a diverse and inclusive workforce. Employment decisions are based on qualifications and business needs without discrimination based on legally protected characteristics.

For reasonable accommodation requests, contact taaccommodationsrequest@fortrea.com.

For more information, visit www.fortrea.com.