Safety & Pharmacovigilance Specialist I – Mandarin / Chinese Speaker
Location: India (Remote)
Employment Type: Full-Time
Job Category: Pharmacovigilance / Drug Safety
Experience Required: 0–2 Years (Freshers Welcome)
Job ID: 25104378
Shift Timings: Tuesday to Saturday | 3:00 PM – 12:00 AM IST
Last Updated: January 2, 2026
About the Company
Syneos Health® is a globally integrated biopharmaceutical solutions organization dedicated to accelerating customer success across clinical development, medical affairs, and commercial functions. With operations in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health partners with pharmaceutical and biotech companies to bring life-changing therapies to patients worldwide.
Driven by innovation, agility, and a patient-first approach, Syneos Health offers a collaborative and inclusive work environment where talent can thrive at the intersection of healthcare and technology.
Job Overview
The Safety & Pharmacovigilance Specialist I – Mandarin/Chinese Speaker will support global pharmacovigilance operations with a focus on Individual Case Safety Report (ICSR) processing, quality review, regulatory compliance, and medical translation activities. This role is ideal for life science graduates with strong Mandarin/Chinese language skills who are looking to build a career in drug safety and pharmacovigilance within a global organization.
Key Responsibilities
Perform end-to-end processing and tracking of Individual Case Safety Reports (ICSRs) in accordance with SOPs, GVP, ICH, and regulatory requirements
Triage safety cases and evaluate data for completeness, accuracy, and reportability
Enter and maintain safety data in pharmacovigilance databases, including MedDRA coding
Compile clear, accurate, and compliant safety narratives
Identify missing information, generate queries, and ensure timely resolution
Support expedited and non-expedited regulatory safety reporting
Perform literature screening and safety data review activities
Manage duplicate case identification and reconciliation
Support xEVMPD submissions, SPOR/IDMP-related activities, and product dictionary maintenance
Conduct quality review of ICSRs and ensure audit readiness
Ensure proper filing of safety documentation in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Apply regulatory intelligence and global safety requirements to daily pharmacovigilance activities
Collaborate effectively with cross-functional and global stakeholders
Participate in internal and external audits as required
Required Qualifications
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline
Science graduates preferred; equivalent qualifications may be considered
Experience:
0–2 years of experience in Pharmacovigilance, Drug Safety, or Clinical Research
Freshers with strong academic background and relevant skillsets are encouraged to apply
Prior exposure to pharmacovigilance case processing is an advantage
Language Requirements
Mandarin / Chinese Proficiency:
HSK Level 4 minimum (HSK 5 or above preferred)
Strong written translation skills (critical requirement)
Conversational speaking proficiency acceptable
Technical & Professional Skills
Knowledge of medical terminology and safety databases
Understanding of clinical trial processes (Phases II–IV) and/or post-marketing safety requirements
Familiarity with ICH-GCP, GVP, and global pharmacovigilance regulations
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and internet tools
Strong attention to detail with high accuracy standards
Excellent written and verbal communication skills
Ability to work independently as well as in a global team environment
Why Join Syneos Health
Opportunity to work on the majority of novel FDA- and EMA-approved therapies globally
Structured career development, technical training, and mentorship programs
Inclusive and diverse workplace culture that values authenticity and collaboration
Exposure to global pharmacovigilance projects and international stakeholders
Equal Opportunity Statement
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, age, disability, sexual orientation, veteran status, or any other legally protected characteristic. Employment decisions are based solely on business needs, merit, and qualifications.
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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