Safety & Pharmacovigilance Specialist I (Quality Control Experience)
Job Requisition ID: 25104167
Employment Type: Full-Time
Work Mode: Office-Based
Locations: Gurugram | Hyderabad | Pune (India)
Experience Required: Minimum 3 Years
Functional Area: Pharmacovigilance | Drug Safety | Case Processing & QC
About the Company
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success across the product lifecycle. By combining deep clinical, medical affairs, and commercial expertise, Syneos Health delivers innovative solutions that place patients at the center of everything we do.
With a presence across more than 110 countries and a workforce of over 29,000 professionals, Syneos Health fosters a culture of innovation, collaboration, and continuous improvement in global drug development and safety.
Position Overview
Syneos Health is seeking a Safety & Pharmacovigilance Specialist I with strong Quality Control (QC) experience to support end-to-end pharmacovigilance operations. This role focuses on Individual Case Safety Report (ICSR) processing, quality review, regulatory compliance, and safety data integrity across clinical trial and post-marketing environments.
The ideal candidate will bring hands-on experience in case processing and QC activities, along with a strong understanding of global safety regulations and pharmacovigilance systems.
Key Responsibilities
Case Processing & Quality Control
Enter, review, and track ICSRs within pharmacovigilance quality and safety databases
Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
Perform quality review of ICSRs in compliance with SOPs, work instructions, and project-specific safety plans
Code adverse events, medical history, concomitant medications, tests, and indications using MedDRA and WHO Drug dictionaries
Compile clear, concise, and medically accurate case narratives
Regulatory Compliance & Reporting
Support the generation and submission of expedited safety reports in accordance with global regulatory requirements
Identify missing or inconsistent data, generate queries, and ensure timely resolution
Maintain safety tracking and documentation for assigned activities
Apply Syneos Health regulatory intelligence to all safety reporting activities
Data Management & Special Safety Activities
Perform literature screening and safety review activities
Manage duplicate ICSR identification and resolution
Support xEVMPD submissions, including validation and MedDRA-based indication coding
Conduct manual recoding of un-recoded product and substance terms
Participate in SPOR / IDMP-related activities
Documentation, Audits & Collaboration
Ensure accurate and timely submission of safety documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Participate in internal and external audits as required
Maintain compliance with GCP, ICH guidelines, GVP modules, and global safety regulations
Collaborate effectively with internal teams and external stakeholders to ensure high-quality safety deliverables
Education & Experience Requirements
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline
Equivalent education and relevant experience may be considered
Experience:
Minimum 3 years of experience in pharmacovigilance case processing with Quality Control (QC) responsibilities
Hands-on experience with clinical trial, post-marketing surveillance (PMS), and spontaneous cases
Working knowledge of safety databases and medical terminology
Solid understanding of clinical trial phases II–IV and post-marketing safety requirements
Strong knowledge of ICH-GCP, GVP modules, and global pharmacovigilance regulations
Required Skills & Competencies
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook)
Strong attention to detail with a high level of accuracy
Excellent written and verbal communication skills
Ability to manage multiple tasks and meet strict timelines
Strong organizational and analytical capabilities
Ability to work independently as well as collaboratively within cross-functional teams
Why Join Syneos Health
Work with a globally recognized leader in drug safety and clinical research
Gain exposure to diverse therapeutic areas and global safety programs
Access structured career development, technical training, and performance recognition
Be part of an inclusive, high-performance, and patient-focused culture
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment and accessibility regulations across jurisdictions.
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