Fortrea is hiring for Safety Science Coordinator I (Pune – Hybrid) and Regulatory Operations Assistant I (Mumbai). These pharma regulatory jobs are ideal for B.Pharm, M.Pharm, PharmD, Life Sciences, and regulatory professionals seeking careers in pharmacovigilance and regulatory operations.
With deadlines closing soon, candidates interested in drug safety jobs in Pune, regulatory affairs jobs in Mumbai, and Fortrea pharma careers 2026 should apply immediately.
Job Overview
The Safety Science Coordinator I supports Clinical Safety and Pharmacovigilance (PV) operations, managing adverse event (AE/SAE) processing, expedited safety reports (ESRs), and regulatory submissions.
Key Responsibilities
- Process Expedited Safety Reports (ESRs) & Periodic Safety Reports (PSRs)
- Maintain adverse event tracking systems
- Write patient safety narratives
- Code adverse events using MedDRA
- Perform listedness assessment for marketed products
- Submit SAE reports to regulatory authorities within timelines
- Assist in database reconciliation & quality review
- Ensure compliance with GCP, SOPs & regulatory requirements
Qualifications
- B.Pharm, M.Pharm, PharmD, Life Sciences, Nursing, Biological Sciences
- 0–2 years pharmacovigilance or drug safety experience
- Knowledge of AE/SAE processing & safety databases
- Good written and verbal English communication
Salary Range (Estimated)
₹3.5 – ₹6 LPA (based on industry standards)
Location
Pune (Hybrid Mode)
2️⃣ Regulatory Operations Assistant I – Mumbai
Job Overview
The Regulatory Operations Assistant I supports regulatory documentation, GMP compliance, analytical testing, and submission support for US, EU, Japan, and ROW health authorities.
Key Responsibilities
- Create and revise regulatory specifications & documents
- Perform API and Finished Product analysis (Assay, Dissolution, Related Substances)
- Ensure compliance with GLP, GDP, cGMP & ICH Guidelines
- Handle instruments like HPLC, GC, UPLC, Dissolution apparatus
- Support regulatory documentation management
- Maintain training & compliance records
Qualifications
- Bachelor’s in Pharmacy or related science (Mandatory)
- 0–3 years experience in Regulatory Affairs / QA / Analytical Science
- Understanding of GxP, ICH-GCP guidelines
- Proficiency in MS Office & documentation tools
Salary Range (Estimated)
₹3 – ₹5.5 LPA
Location
Mumbai (Office-based)
Why Join Fortrea?
- Global CRO exposure
- Strong regulatory & pharmacovigilance career growth
- Hybrid work opportunity (Safety role)
- Exposure to US, EU & Japan regulatory submissions
- Opportunity to build expertise in drug safety and regulatory compliance
Application Details
Application Link For Safety Science Coordinator I
Application Link For Regulatory Operations Assistant I
