Safety & Pharmacovigilance Specialist I – Mandarin / Chinese Speaker
Job Requisition ID: 25104378
Employment Type: Full-Time
Work Mode: Remote (Exception Approved)
Location: India – Remote
Experience Required: Fresher to 2 Years
Shift Timing: Tuesday to Saturday | 3:00 PM – 12:00 AM IST
Functional Area: Pharmacovigilance | Drug Safety | ICSR Processing
About the Company
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative solutions that address evolving market and patient needs.
With more than 29,000 employees across 110+ countries, Syneos Health fosters a collaborative, inclusive, and performance-driven culture focused on improving patient safety and advancing global healthcare.
Position Overview
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I – Mandarin/Chinese Speaker to support global drug safety operations. This role is ideal for science graduates and early-career pharmacovigilance professionals, including freshers with strong Mandarin/Chinese language proficiency.
The position focuses on ICSR case processing, safety data quality, literature review, and regulatory compliance, with a strong emphasis on translation and linguistic accuracy for Mandarin/Chinese safety data.
Key Responsibilities
Case Processing & Safety Operations
Enter and track Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and safety databases
Assist in ICSR processing in compliance with SOPs and project-specific safety plans
Perform ICSR triage and assess data for completeness, accuracy, and regulatory reportability
Code adverse events, medical history, concomitant medications, and tests using MedDRA and drug dictionaries
Prepare clear, accurate, and compliant case narratives
Identify missing information, generate follow-up queries, and ensure timely resolution
Quality, Compliance & Data Management
Support timely preparation of expedited safety reports in line with global regulatory requirements
Maintain safety tracking logs and documentation
Perform quality review of ICSRs
Identify and manage duplicate safety cases
Support xEVMPD submissions, including MedDRA-based indication coding
Perform manual recoding of product and substance terms arising from ICSRs
Participate in SPOR / IDMP-related pharmacovigilance activities
Literature & Documentation
Conduct literature screening and safety review activities
Support maintenance of drug dictionaries and coding standards
Ensure timely filing of documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Participate in audits and inspections as required
Education & Experience Requirements
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline
Equivalent education and relevant experience may be considered
Experience:
Freshers are welcome to apply
Up to 2 years of experience in Pharmacovigilance or Drug Safety is an advantage but not mandatory
Language Proficiency (Mandatory)
Mandarin / Chinese: HSK Level 4 minimum (HSK 5 or above preferred)
Writing: Strong proficiency required
Translation: Critical skill for the role
Speaking: Conversational proficiency acceptable
Technical & Professional Skills
Familiarity with pharmacovigilance safety databases and medical terminology
Basic understanding of clinical trial phases (II–IV) and/or post-marketing safety requirements
Knowledge of ICH-GCP, GVP modules, and global PV regulations is an advantage
Proficiency in MS Office tools (Word, Excel, PowerPoint, Outlook)
Strong attention to detail with high data accuracy
Ability to work independently and collaboratively in global teams
Excellent communication, organizational, and time-management skills
Work Schedule
Tuesday to Saturday | 3:00 PM – 12:00 AM IST
Flexibility required based on business needs; occasional shift extensions may apply
Why Join Syneos Health
Opportunity to begin or advance a global career in Pharmacovigilance
Work on international safety programs with multilingual exposure
Structured training, mentoring, and career development support
Inclusive culture that values diversity, language skills, and innovation
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and complies with all applicable employment and accessibility regulations.
Apply now on thepharmadaily.com to start your career in Pharmacovigilance, Drug Safety, and Global Safety Operations with a leading biopharmaceutical organization.
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Auckland |New Zealand :
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