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Safety & Pv Specialist I - Mandarin/Chinese Speaker

Syneos Health
Syneos Health
0-2 years
preferred by company
10 Jan. 12, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.