Job Title: Safety & PV Specialist I – QC Experience
Location: Gurugram / Hyderabad / Pune, India (Remote Type – Office-Based)
Employment Type: Full-Time
Experience Required: Minimum 3 years in pharmacovigilance case processing and QC
Qualification: Bachelor’s in Life Sciences, Pharmacy, Nursing, or equivalent
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, delivering clinical, medical affairs, and commercial insights to accelerate customer success. With a global footprint across 110 countries and over 29,000 employees, Syneos Health focuses on innovative, patient-centered solutions and streamlining clinical operations for optimal outcomes.
We are committed to career development, supportive leadership, diversity, and inclusion, creating a workplace where employees can thrive, innovate, and make a meaningful impact.
Role Overview:
The Safety & PV Specialist I will contribute to pharmacovigilance operations, performing ICSR case processing, QC review, and safety reporting in compliance with global regulations, ICH-GCP guidelines, and company SOPs. This role supports clinical trials, post-marketing safety, and regulatory submissions, ensuring high-quality safety data management.
Key Responsibilities:
1. Case Processing & Quality Control:
Enter and track ICSRs in PVG quality systems, ensuring data completeness, accuracy, and regulatory reportability.
Triage cases, code events, medical history, concomitant medications, and tests.
Compile complete narrative summaries and follow up on queries until resolution.
Conduct quality review and QC of ICSRs for clinical trial, post-marketing, and spontaneous cases.
Identify and manage duplicate cases and maintain case tracking documentation.
2. Regulatory Compliance & Reporting:
Validate and submit xEVMPD product records, including MedDRA-coded indications.
Ensure all clinical and safety documentation is properly filed in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Apply regulatory intelligence to all safety reporting activities.
Support audits and inspections as required.
3. Safety Database & Tools:
Maintain knowledge of safety databases and tools for case entry, tracking, and reporting.
Perform literature screening and review, drug coding, and maintenance of drug dictionaries.
Support SPOR/IDMP-related activities and ensure database integrity.
4. Collaboration & Communication:
Foster professional working relationships with project teams, internal stakeholders, and external partners.
Collaborate with cross-functional teams including Clinical, Medical, and Regulatory Affairs.
Maintain clear, accurate communication and reporting within project and study teams.
Qualifications & Skills:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
Minimum 3 years of pharmacovigilance experience, including case processing and QC.
Experience with clinical trials, post-marketing safety (PMS), and spontaneous cases.
Knowledge of safety databases, medical terminology, MedDRA coding, and global pharmacovigilance regulations (GVP, ICH-GCP).
Proficiency in Microsoft Office Suite, SharePoint, and collaborative tools.
Strong attention to detail, organizational skills, and ability to prioritize multiple tasks.
Excellent interpersonal, written, and verbal communication skills.
Ability to work independently and in team environments.
Why Join Syneos Health:
Work with cutting-edge clinical and medical projects impacting global patient care.
Access to continuous career development, training, and growth opportunities.
Be part of a diverse, inclusive, and supportive workplace culture.
Contribute to patient safety, innovative therapies, and regulatory excellence worldwide.
Gujarat :
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