Job Title:
Safety & Pharmacovigilance Specialist I
Company:
Syneos Health
Location:
India-Asia Pacific - Hyderabad-Raheja-Mindspace, India
Job ID:
25001642
Job Type:
Full-Time
Role Overview:
The Safety & Pharmacovigilance Specialist I will assist in processing Individual Case Safety Reports (ICSRs) in accordance with SOPs and safety plans. Responsibilities include entering data into safety databases, ensuring the accuracy of regulatory reports, performing literature screening, coding events, and ensuring compliance with global regulations related to Safety and Pharmacovigilance.
Key Responsibilities:
Safety Reporting and Data Management:
Enter information into PVG quality and tracking systems for ICSRs.
Process and triage ICSRs, ensuring completeness, accuracy, and regulatory reportability.
Code events, medical history, medications, and tests; compile narrative summaries.
Validate and submit xEVMPD product records, including MedDRA coding.
Regulatory Compliance:
Ensure timely, consistent, and accurate reporting of expedited reports per regulatory requirements.
Maintain understanding and compliance with SOPs, GCP, ICH guidelines, GVP, and drug development processes.
Participate in audits and ensure readiness for safety inspections.
Quality and Documentation:
Perform quality review of ICSRs and manage duplicate cases.
Ensure all relevant documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File.
Apply safety reporting regulatory intelligence to all safety reporting activities.
Team Collaboration:
Foster professional working relationships with internal and external project team members.
Support and contribute to safety and pharmacovigilance activities across clinical trials and post-marketing programs.
Requirements:
Education:
Bachelor’s degree in life sciences, nursing, pharmacy, or an equivalent combination of education and experience.
Experience:
Knowledge of safety database systems, medical terminology, and clinical trial processes (Phases II-IV and post-marketing).
Proficiency in ICH GCP, GVP, and Safety and Pharmacovigilance regulations.
Skills:
Strong organizational and multitasking skills, with attention to detail and accuracy.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, and Outlook.
Excellent communication skills (written and verbal) and interpersonal skills.
Why Syneos Health?
Syneos Health offers career development opportunities, a supportive and engaging work culture, and a commitment to diversity and inclusion.
The company has worked with 94% of FDA-approved drugs and 95% of EMA-authorized products over the past 5 years, contributing to the advancement of therapies.
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