Fortrea, a leading global contract research organization (CRO), is hiring for four critical roles in Regulatory Operations, Safety Science, and Medical Coding. If you have experience in pharmaceutical regulatory submissions, pharmacovigilance, or clinical data coding, this is an excellent opportunity to advance your career with a reputed organization.
Location: Pune & Bangalore (Hybrid/Remote/Office-Based)
Job Type: Full-Time
Industry: Pharmaceuticals / Clinical Research
1. Senior Regulatory Operations Specialist (Hybrid – Pune)
Job ID: 25124
Apply Before: April 8, 2025
Job Description:
- Prepare, compile, and review CMC (Chemistry, Manufacturing, Controls) & regulatory documents for global submissions.
- Manage raw material & packaging specifications, change control assessments, and supplier agreements.
- Support global labeling projects, stability data evaluation, and import/export license submissions.
- Train junior staff and ensure compliance with regulatory standards.
Key Skills: Regulatory Affairs, CMC Documentation, Change Control, Packaging Compliance.
2. Safety Science Specialist (Bangalore – Office-Based)
Job ID: 25684
Apply Before: April 8, 2025
Job Description:
- Process adverse event (AE) reports from clinical trials and post-marketing surveillance.
- Perform MedDRA coding, case narrative writing, and expedited reporting to regulatory agencies.
- Assist in periodic safety reports (PSRs), database reconciliation, and audit readiness.
- Ensure compliance with SOPs, ICH-GCP, and pharmacovigilance regulations.
Qualifications: 3-4 years of drug safety/pharmacovigilance experience, MedDRA coding knowledge.
3. Coding Specialist I (Remote – Bangalore)
Job ID: 251846
Apply Before: June 30, 2025
Job Description:
- Perform medical coding (MedDRA/WHODrug) for clinical trial data.
- Assist in thesaurus management, data quality checks, and coding conventions.
- Collaborate with data management teams to ensure accurate and timely deliverables.
Requirements: 4-6 years in clinical data management, familiarity with Medidata Coder/Central Coding.
4. Coding Specialist II (Remote – Bangalore)
Job ID: 251848
Apply Before: June 30, 2025
Job Description:
- Lead medical coding activities for global clinical trials.
- Review Data Management Plans (DMPs) and coding guidelines.
- Support dictionary verification (MedDRA/WHODrug) and process improvements.
Preferred: MedDRA certification, 6-8 years in clinical coding, expertise in CDISC/SDTM standards.
About Fortrea
Fortrea is a top-tier Contract Research Organization (CRO) providing clinical trial management, regulatory consulting, and pharmacovigilance services to biotech and pharmaceutical firms. With a strong global presence, Fortrea is known for its innovative solutions and compliance-driven approach in drug development.
How to Apply?
Application Link For Senior Regulatory Operations Specialist
Application Link For Safety Science Specialist
