Safety Science Analyst

Why This Role Matters
The Safety Science Analyst plays an important role in monitoring and managing drug safety data in clinical research and post-marketing environments. By handling adverse event reports, documenting safety information, and ensuring timely regulatory submissions, the analyst helps protect patient safety and supports compliance with global pharmacovigilance standards.

Job Description
Fortrea is hiring a Safety Science Analyst for a 6-month contract position in Pune. The role involves supporting pharmacovigilance operations by processing adverse event reports, maintaining safety databases, preparing safety documentation, and assisting with regulatory submissions while ensuring compliance with quality and safety standards.

Key Features of the Role
• Position: Safety Science Analyst
• Company: Fortrea
• Location: Pune, Maharashtra, India
• Employment Type: Contract (6 Months)
• Workplace Type: Office-based
• Experience: 0–1 year of pharmacovigilance or relevant experience
• Category: Clinical / Pharmacovigilance

Responsibilities
• Perform case intake and triage of incoming safety reports from clinical trials or spontaneous sources
• Enter safety data into adverse event tracking and safety database systems
• Write patient safety narratives and code adverse events using MedDRA terminology
• Assist in listedness assessment against appropriate product labels when applicable
• Generate queries and obtain missing or inconsistent information in coordination with medical teams
• Submit expedited serious adverse event (SAE) reports to clients, regulatory authorities, and investigators within timelines
• Assist in preparing and submitting periodic and expedited safety reports to global regulatory agencies
• Support reconciliation of safety databases when required
• Maintain documentation related to adverse event reporting requirements across regions
• Upload and archive safety case documentation and study records
• Follow company SOPs, quality systems, and pharmacovigilance regulations
• Collaborate with cross-functional teams to maintain effective safety operations

Required Qualification
• B.Pharm, M.Pharm, Pharm D, BAMS, BDS, BHMS, or Nursing degree

Important Requirements
• 0–1 year of pharmacovigilance, clinical safety, or relevant healthcare experience
• Strong attention to detail and accuracy in data handling
• Good written and verbal communication skills
• Basic knowledge of MS Office applications
• Ability to work effectively in a team environment
• Understanding of clinical safety processes is preferred

What We Offer
• Opportunity to work in a global clinical research organization
• Exposure to pharmacovigilance and clinical safety operations
• Experience with safety databases and regulatory reporting processes
• Professional work environment with industry-standard safety practices
• Opportunity to develop skills in drug safety and regulatory compliance

Experience and Skills
• Adverse event case processing and safety data entry
• Medical narrative writing and MedDRA coding
• Pharmacovigilance documentation and regulatory reporting
• Safety database management and reconciliation support
• Attention to detail and data accuracy
• Communication and teamwork in clinical research settings

Salary Insights
• Salary details not specified in the job listing
• Compensation may vary depending on qualifications and experience

Company Overview
Fortrea is a global clinical research organization that supports pharmaceutical, biotechnology, and medical device companies in developing life-changing treatments. The company specializes in clinical trials, pharmacovigilance, regulatory services, and drug development solutions while maintaining high standards of patient safety and data integrity.

FAQs

1. What qualifications are required for this role?
   Candidates must hold a B.Pharm, M.Pharm, Pharm D, BAMS, BDS, BHMS, or Nursing degree.

2. Is prior experience required?
   0–1 year of pharmacovigilance or related healthcare experience is preferred.

3. What does the Safety Science Analyst do?
   The analyst processes adverse event reports, manages safety data, writes narratives, and supports regulatory submissions.

4. Where is the job located?
   The position is office-based in Pune, Maharashtra.

Application Tips
• Highlight your pharmacovigilance or clinical safety knowledge
• Mention experience with adverse event processing or safety databases
• Include details of your healthcare qualification (B.Pharm, BDS, Nursing, etc.)
• Demonstrate attention to detail and data management skills
• Emphasize teamwork and communication abilities