Safety & Pharmacovigilance Specialist I – Mandarin / Chinese Speaker
Company: Syneos Health
Job ID: 25104378
Location: India – Remote
Employment Type: Full-Time
Experience Required: 0–2 Years (Freshers Welcome)
Languages Required: Mandarin / Chinese (HSK 4 minimum)
Shift Timing: Tuesday to Saturday | 3:00 PM – 12:00 AM IST
Posted On: January 2, 2026
Job Overview
Syneos Health, a global biopharmaceutical solutions organization, is seeking a Safety & Pharmacovigilance Specialist I with Mandarin/Chinese language proficiency to support global drug safety operations. This role is ideal for entry-level professionals or fresh life science graduates aspiring to build a long-term career in Pharmacovigilance and Drug Safety within a regulated global environment.
The position supports clinical trial and post-marketing safety activities, including ICSR processing, safety database management, regulatory reporting, and global compliance.
Key Responsibilities
Pharmacovigilance Case Processing
Receive, triage, process, and track Individual Case Safety Reports (ICSRs) in compliance with SOPs and project-specific safety plans
Perform data entry, medical review support, and quality checks for accuracy, completeness, and regulatory reportability
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and drug dictionaries
Compile and review comprehensive case narratives
Regulatory Reporting & Compliance
Support expedited safety reporting in line with global regulatory timelines
Assist in duplicate case identification and reconciliation
Validate and submit xEVMPD product records, including MedDRA-based indication coding
Support SPOR / IDMP-related activities
Literature & Data Management
Conduct literature screening and review for safety-relevant information
Maintain drug dictionaries and perform manual recoding where required
Ensure proper filing of safety documentation in TMF and PSMF
Quality, Audits & Collaboration
Perform quality review of ICSRs
Participate in internal and external audits as required
Maintain compliance with ICH GCP, GVP, SOPs, WIs, and global regulatory requirements
Collaborate effectively with global cross-functional and multicultural teams
Education & Experience Requirements
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline
Experience:
0–2 years of experience in Pharmacovigilance or Drug Safety
Fresh graduates with strong regulatory interest are encouraged to apply
Prior exposure to safety databases or PV operations is an advantage
Language Requirements (Mandatory)
Mandarin / Chinese Proficiency:
HSK 4 minimum (HSK 5 or above preferred)
Writing: Critical
Speaking: Conversational proficiency acceptable
Translation skills: Highly important
Technical & Professional Skills
Knowledge of pharmacovigilance processes and medical terminology
Understanding of clinical trial phases (II–IV) and/or post-marketing safety
Familiarity with ICH, GCP, GVP, and global safety regulations
Proficiency in MS Word, Excel, PowerPoint, Outlook, and internet tools
Strong attention to detail, time management, and documentation accuracy
Ability to work independently and within a global team environment
Work Schedule
Fixed night shift: Tuesday to Saturday, 3:00 PM – 12:00 AM IST
Flexibility required based on project and business needs
Why Join Syneos Health
Work with a company involved in 94% of FDA novel drug approvals and 95% of EMA-authorized products
Exposure to global clinical trials and post-marketing safety programs
Structured training, career development, and global mobility opportunities
Inclusive, diverse, and people-centric work culture
About Syneos Health
Syneos Health is a leading global biopharmaceutical solutions organization with over 29,000 professionals across 110 countries. The company partners with biopharma innovators to accelerate the development and commercialization of therapies that improve patient outcomes worldwide.
Apply now on ThePharmaDaily.com to launch or accelerate your career in global Pharmacovigilance and Drug Safety.
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