Syneos Health is hiring Safety Specialist II – ICSR Case Processing for its offices in Gurgaon, Hyderabad (Hybrid), and Pune (Hybrid). If you are looking to advance your career in Pharmacovigilance, this opportunity offers stable growth, global exposure, and a chance to contribute to critical drug safety processes.
This job is ideal for candidates with strong knowledge of ICSR processing, MedDRA coding, GVP guidelines, and clinical safety reporting.
⭐ Why Join Syneos Health?
- Work with a global leader supporting 94% of FDA-approved novel drugs in the past five years.
- Strong learning ecosystem, career development, and total rewards program.
- Supportive “Total Self” culture promoting authenticity and well-being.
- Collaborative and innovation-driven PV environment.
📌 Job Responsibilities
As a Safety Specialist II – ICSR Case Processing, you will:
- Enter ICSR details into PV quality and tracking systems.
- Perform ICSR triage, completeness checks, regulatory reportability assessment.
- Enter cases into safety database with accurate MedDRA coding.
- Prepare high-quality narrative summaries.
- Identify missing information and follow up on safety queries.
- Support timely expedited and periodic reporting per global regulations.
- Manage duplicate ICSR identification and resolution.
- Perform literature screening and drug dictionary maintenance.
- Validate and submit xEVMPD product records using MedDRA.
- Conduct SPOR/IDMP-related activities.
- Perform quality review of processed cases.
- Ensure proper documentation within TMF and PSMF.
- Maintain compliance with SOPs, GVP, GCP, ICH guidelines.
- Participate in audits as required.
🎓 Qualifications & Skills Required
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
- Strong knowledge of Medical Terminology, Safety Databases, and ICSR lifecycle.
- Understanding of Phase II–IV clinical trials and post-marketing PV requirements.
- Good command of Microsoft Office tools and shared workspace systems.
- Excellent written and verbal communication skills.
- Strong attention to detail, accuracy, and ability to meet timelines.
- Capable of working independently and collaboratively.
⭐ Benefits of Working at Syneos Health
- Global PV process exposure.
- Career advancement opportunities.
- Comprehensive onboarding & technical training.
- Supportive leadership & employee recognition programs.
- Diverse and inclusive work culture.
📝 How to Apply
