Are you a life sciences professional passionate about clinical safety, pharmacovigilance, and regulatory compliance? Fortrea is hiring a Senior Safety Science Specialist in Pune. This full-time role offers the chance to work on global clinical safety operations, manage adverse event reporting, and support regulatory submissions.
This opportunity is ideal for candidates with experience in drug safety, clinical data management, regulatory affairs, or pharmacovigilance who want to advance their careers with a leading global CRO.
🔹 Key Responsibilities
As a Senior Safety Science Specialist, you will:
- Manage receipt and processing of all adverse event (AE) and serious adverse event (SAE) reports from clinical trials and post-marketing settings.
- Perform data entry, case review, patient narratives, and MedDRA coding.
- Ensure timely expedited reporting to regulatory authorities, ethics committees, investigators, and clients.
- Assist in preparation of Expedited Safety Reports (ESRs), Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs).
- Conduct database reconciliation with data management teams or sponsors.
- Participate in signal detection, trend analysis, and risk management activities.
- Support audits, inspections, and preparation of safety management plans.
- Mentor junior safety staff and ensure compliance with ICH-GCP guidelines.
🎓 Qualifications
- Education: Degree in Pharmacy, Nursing, Life Sciences, or related fields.
- Experience:
- Non-degree: 4-5 years relevant experience.
- Associate degree: 3-4 years.
- Bachelor’s: 2-3 years.
- Master’s/PharmD: 1-2 years.
- Hands-on experience in:
- Case processing (AE/SAE)
- Narrative writing & safety database handling
- Regulatory submissions & pharmacovigilance compliance
- Knowledge of ICH-GCP, MedDRA, and global PV regulations.
- Strong attention to detail, MS Office skills, and ability to work independently.
💼 Why Join Fortrea?
- Work in a global CRO with exposure to international safety operations.
- Gain expertise in drug safety and pharmacovigilance regulations.
- Collaborative work environment with opportunities for career growth.
- Competitive salary and professional development support.
📌 Application Process
