Safety Science Specialist Job in Pune – Fortrea Hiring

Are you looking for a career in drug safety and pharmacovigilance? Fortrea is hiring a Safety Science Specialist in Pune. This role is ideal for professionals with experience in adverse event reporting, clinical trial safety, and regulatory submissions. With only limited time left to apply, this is your chance to step into a global career in clinical safety.

Key Responsibilities

As a Safety Science Specialist at Fortrea, you will:

• Manage the receipt and processing of adverse event (AE) and serious adverse event (SAE) reports.
• Perform data entry of safety data into safety databases and tracking systems.
• Review adverse events for completeness, accuracy, and compliance with global regulations.
• Write patient narratives and code AEs using MedDRA.
• Ensure appropriate expedited safety reporting to clients, health authorities, and ethics committees.
• Support database reconciliation with data management teams.
• Assist in preparation of periodic safety reports (PSRs) and expedited safety reports (ESRs).
• Conduct quality reviews of processed reports and participate in audits.
• Maintain strong knowledge of pharmacovigilance SOPs, GVP guidelines, and regulatory directives.
• Support root cause analysis, CAPA plans, and safety committees/DSMBs as required.

Qualifications

To qualify for the Safety Science Specialist role in Pune, candidates should have:

• Degree in Pharmacy, Nursing, Life Sciences, Biological Sciences, or Medical Sciences.
• Experience requirements:
  • Non-degree + 2 years safety experience OR 3–4 years relevant pharma/CRO experience.
  • Associate/Bachelor’s/Master’s/PharmD with 1–3 years of safety or relevant experience.
• Hands-on experience in pharmacovigilance case processing, narrative writing, and regulatory submissions.
• Strong attention to detail and excellent communication skills.
• Knowledge of MS Office, safety databases, and medical coding systems.

Benefits of Working at Fortrea

• Opportunity to work with a global CRO on diverse projects.
• Exposure to international regulatory compliance and pharmacovigilance operations.
• Collaborative and growth-oriented work culture.
• Flexibility with office or remote work options.

How to Apply

Application Link