Fortrea Hiring: Senior Safety Science Specialist – Life Sciences | Pune

Senior Safety Science Specialist at Fortrea – Pune | Biological Sciences, Pharmacy, Nursing, Life Sciences | 2+ Years of Experience

Looking to elevate your career in clinical safety? Fortrea invites applications for the Senior Safety Science Specialist role at its Pune location. This full-time position is ideal for professionals with 2+ years of safety experience or equivalent experience in Life Sciences, Pharmacy, or Clinical Data domains.

Apply now to become a core part of Fortrea’s mission to advance health through clinical research excellence.

Join Fortrea as a Senior Safety Science Specialist – Pune Location

Fortrea, a leading global CRO, is hiring a Senior Safety Science Specialist to support critical safety and pharmacovigilance operations. Based in Pune, this full-time position involves processing adverse event reports, contributing to clinical trial safety, and ensuring compliance with global regulatory standards.

This is a high-impact role in a rapidly growing organization that values accuracy, quality, and cross-functional collaboration.

About Fortrea

Fortrea is at the forefront of clinical development, offering end-to-end solutions to pharmaceutical and biotechnology clients. With a strong emphasis on patient safety, compliance, and scientific rigor, Fortrea operates globally, providing clinical trial support and data-driven insights that contribute to safe and effective treatments.

Key Responsibilities

Clinical Safety & Adverse Event Management

• Process spontaneous and clinical trial adverse event reports
• Ensure accurate data entry and tracking of safety data in internal systems
• Review, write, and submit serious adverse event (SAE) reports to regulatory bodies
• Write patient narratives and apply MedDRA coding
• Perform listedness assessments for marketed products

Documentation & Quality Oversight

• Maintain adverse event tracking systems and project files
• Participate in quality reviews and database reconciliations
• Assist with creation of Safety Management Plans (SMPs) and Reconciliation Plans
• Support periodic safety reports like DSURs, PSURs, and Annual IND reports

Collaboration & Mentorship

• Collaborate with data management, clinical, and regulatory teams
• Provide training and mentorship to junior team members
• Participate in audits and inspections, contribute to CAPA planning
• Engage in safety signal detection and trend analysis

Required Qualifications

• Education:
  • Non-degree + 4–5 years of experience
  • Associate degree + 3–4 years
  • Bachelor’s (BS/BA) + 2–3 years
  • Master’s (MS/MA) + 2 years
  • PharmD + 2 years (including fellowship/residency)
  • Preferred fields: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences
• Experience:
  • Proven track record in safety case processing, MedDRA coding, and SAE submissions
  • Familiarity with GCP, ICH guidelines, and global safety regulations
  • Strong communication and presentation skills
  • Proficient in Microsoft Office and safety databases

Physical Demands & Work Conditions

• Location: Pune, Maharashtra
• Type: Full-time
• Travel: Up to 5%, based on project needs

Why Join Fortrea?

• Opportunity to work on global safety projects
• Supportive, inclusive workplace culture
• Growth opportunities within a leading CRO
• Competitive salary and benefits

Call to Action

Apply now through the official Fortrea Careers portal:
https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Pune/Senior-Safety-Science-Specialist_252177

Submit your updated resume and highlight relevant safety and pharmacovigilance experience.

Quick Overview Table

Apply for Senior Safety Science Specialist role at Fortrea, Pune. Ideal for Life Sciences, Pharmacy, or Nursing graduates with 2+ years of pharmacovigilance experience.