Safety & PV Specialist I – Mandarin/Chinese Speaker (Remote, India)
Location: Remote – India
Job Type: Full-Time
Job ID: 25104378
Updated: January 2, 2026
About Syneos Health
Syneos Health is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, commercial insights, and advanced operational services, we deliver innovative solutions to bring meaningful therapies to patients faster.
With 29,000 employees across 110 countries, Syneos Health promotes a collaborative, inclusive, and high-performance culture, enabling every team member to contribute to transforming healthcare outcomes worldwide.
Position Overview
We are seeking a Safety & Pharmacovigilance (PV) Specialist I with Mandarin/Chinese language proficiency to join our remote India-based team. This role involves processing Individual Case Safety Reports (ICSRs), maintaining safety data, supporting regulatory submissions, and ensuring compliance with global pharmacovigilance standards.
This position is ideal for science graduates or entry-level candidates with strong attention to detail, organizational skills, and interest in pharmacovigilance. Prior PV/Drug Safety experience is an advantage.
Key Responsibilities
Enter and maintain safety information in PVG quality and tracking systems.
Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
Triage ICSRs, evaluate data for completeness, accuracy, and regulatory reportability.
Code adverse events, medical history, concomitant medications, and tests; maintain MedDRA coding standards.
Compile narrative summaries and identify queries for follow-up until resolution.
Support timely reporting of expedited reports in compliance with regulatory requirements.
Maintain safety tracking for assigned activities.
Conduct literature screening and review, update drug dictionaries, and manage xEVMPD product records.
Identify and manage duplicate ICSRs and participate in SPOR/IDMP activities.
Perform quality review of ICSRs and ensure proper documentation in Trial Master File (TMF) and Pharmacovigilance System Master File.
Stay updated on SOPs, GCP, ICH guidelines, GVP, and global drug/biologic/device regulations.
Foster professional working relationships with internal and external teams.
Participate in audits as required.
Required Qualifications
Education & Experience:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or equivalent.
Science graduates preferred; fresher candidates are welcome. Prior PV/Drug Safety experience is a plus.
Language Skills:
Mandarin/Chinese proficiency: HSK 4 minimum; HSK 5+ preferred.
Writing: Critical
Speaking: Conversational acceptable
Translating: Highly important
Technical & Professional Skills:
Experience with safety database systems and medical terminology.
Understanding of clinical trial processes (Phases II–IV) and/or post-marketing safety requirements.
Knowledge of ICH GCP, GVP, and related regulations.
Proficiency in MS Office, Visio, Outlook, Team Share, and internet tools.
Strong interpersonal, organizational, and communication skills.
Detail-oriented with high accuracy and ability to meet deadlines.
Ability to work independently and collaboratively in a team environment.
Shift Timings:
Tuesday to Saturday, 3 PM – 12 AM IST
Flexibility may be required based on business needs.
Why Join Syneos Health
Work remotely in a globally integrated biopharmaceutical environment.
Contribute to critical pharmacovigilance operations supporting drug safety worldwide.
Gain exposure to regulatory standards, PV databases, and global reporting processes.
Join a company that has worked with 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years.
Additional Information
Tasks, duties, and responsibilities are not exhaustive and may evolve with business needs. Syneos Health is an equal opportunity employer and provides reasonable accommodations as required.
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