Fortrea is inviting applications for the position of Safety Science Analyst (Contract) in Pune, India. This is an excellent opportunity for B.Pharm, M.Pharm, and PharmD freshers looking to start a career in Pharmacovigilance (PV) and Clinical Safety Operations within a global CRO environment.
This 6-month contract role focuses on adverse event processing, safety data management, and regulatory reporting—key functions that ensure patient safety and compliance with global pharmacovigilance guidelines.
With increasing global demand for drug safety professionals, PV case processors, and safety data analysts, this role offers strong foundational exposure to real-world safety surveillance and regulatory workflows.
Key Responsibilities – Safety Science Analyst
Selected candidates will support Clinical Safety / Patient Safety Services (PSS) activities, including:
- Perform case intake, triage, and processing of adverse event (AE) reports from clinical trials and post-marketing sources.
- Enter safety data into validated pharmacovigilance databases following SOPs and regulatory timelines.
- Write patient safety narratives and perform accurate MedDRA coding.
- Assist in listedness and causality assessments against product labels.
- Generate and follow up on data queries for incomplete safety information.
- Submit expedited SAE reports to regulatory authorities, ethics committees, and clients.
- Support preparation of periodic safety reports and regulatory submissions.
- Perform database reconciliation and documentation archival activities.
- Ensure compliance with GVP guidelines, Quality Management Systems, and SOP frameworks.
- Maintain global safety reporting documentation and collaborate with cross-functional teams.
Eligibility Criteria
Educational Qualification
- B.Pharm / M.Pharm with 0–6 months experience in Pharmacovigilance or CRO
OR - PharmD (Freshers eligible)
- Certifications in Clinical Research, CDM, or Pharmacovigilance are an added advantage.
Required Skills
- Strong attention to detail and data accuracy.
- Good written and verbal communication skills.
- Knowledge of drug safety workflows and medical terminology preferred.
- Basic proficiency in MS Office tools.
- Ability to work in a structured regulatory environment.
Why This Role is Important for Freshers in Pharmacovigilance
This opportunity provides hands-on experience in:
- ICSR lifecycle management
- Global regulatory reporting timelines
- MedDRA coding and safety database usage
- Clinical trial safety surveillance
- CRO operational exposure
For candidates targeting careers such as Drug Safety Associate, PV Case Processor, Safety Scientist, or Regulatory Safety Specialist, this role serves as a strong entry point.
Salary & Contract Details
- Role Type: Full-Time (6-Month Contract)
- Location: Pune, Maharashtra
- Estimated Salary: ₹3.0 – ₹4.5 LPA (pro-rated for contract duration; industry standard for entry-level PV roles)
- Work Environment: Office-based Clinical Safety Operations
Benefits of Joining Fortrea
- Entry into a global CRO ecosystem.
- Practical exposure to end-to-end pharmacovigilance workflows.
- Experience aligned with ICH-GCP and global safety regulations.
- Opportunity to build a foundation for long-term PV and Clinical Research careers.
- Collaborative environment focused on patient safety and regulatory excellence.
How to Apply
