Safety & Pharmacovigilance Specialist I – Mandarin/Chinese Speaker | Remote – India
Location: India (Remote)
Employment Type: Full-Time, Permanent
Job ID: 25104378
About the Role
Syneos Health®, a global leader in biopharmaceutical solutions, is seeking a Safety & Pharmacovigilance (PV) Specialist I with Mandarin/Chinese proficiency to support drug safety operations across clinical and post-marketing programs.
This entry-level to early-career role is ideal for life sciences graduates, pharmacy, or nursing professionals looking to launch or grow a career in pharmacovigilance while gaining global exposure. You will work within a collaborative PV team to ensure accurate, timely, and compliant safety reporting, contributing to the protection of patient safety worldwide.
Key Responsibilities
Individual Case Safety Report (ICSR) Management
Enter, track, and maintain ICSR data in PVG quality and tracking systems.
Process ICSRs according to SOPs, project-specific safety plans, and global regulations.
Triage and evaluate ICSRs for completeness, accuracy, and reportability.
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA.
Prepare complete narrative summaries and identify missing or inconsistent information for queries.
Assist in timely and compliant expedited reporting for regulatory authorities.
Safety Data Oversight & Quality
Perform literature screening and review for safety signals.
Maintain drug dictionaries and validate/submit xEVMPD product records, ensuring accurate coding.
Identify and manage duplicate ICSRs and perform quality review of case data.
Support activities related to SPOR/IDMP and ensure proper submission to Trial Master Files (TMF).
Compliance & Collaboration
Maintain compliance with SOPs, Work Instructions (WIs), GCP, ICH guidelines, and global PV regulations (GVP).
Foster professional relationships with project team members, both internal and external.
Participate in audits and implement safety reporting regulatory intelligence across all assigned activities.
Required Qualifications
Education & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
Fresher candidates are welcome; prior exposure to pharmacovigilance/drug safety is a plus.
Understanding of clinical trial phases (II–IV) and/or post-marketing safety requirements.
Language Skills
Mandarin/Chinese Proficiency: HSK 4 minimum; HSK 5+ preferred.
Writing: Strong technical writing skills.
Speaking: Conversational level acceptable.
Translating: Critical skill for case processing and reporting.
Technical & Professional Skills
Experience with safety databases and medical terminology.
Knowledge of ICH-GCP, GVP, and related regulatory requirements.
Proficient in MS Office (Word, Excel, PowerPoint, Outlook, Teams).
Detail-oriented, accurate, and able to meet deadlines.
Strong interpersonal, communication, and organizational skills.
Ability to work independently and as part of a remote, global team.
Shift Timings
Tuesday to Saturday, 3 PM – 12 AM IST (night shift).
Flexibility required based on business needs; shift extensions may apply.
Why Join Syneos Health
Be part of a global biopharmaceutical leader impacting patient safety across 110 countries.
Gain experience with regulatory-compliant pharmacovigilance processes and global clinical trials.
Benefit from career development programs, technical training, and mentorship.
Join a company with a diverse, inclusive, and collaborative culture, where your contributions are valued.
Competitive salary and benefits package with opportunities for professional growth.
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization with 29,000 employees globally. We deliver innovative clinical, medical affairs, and commercial solutions to accelerate the delivery of therapies worldwide. Our commitment to diversity, innovation, and excellence creates a workplace where everyone belongs, and every role impacts global healthcare outcomes.
Apply Now
Start your career as a Safety & PV Specialist I at Syneos Health and gain hands-on experience in global pharmacovigilance and drug safety operations while leveraging your Mandarin/Chinese language skills.
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