Safety & Pharmacovigilance Specialist I – Mandarin/Chinese Speaker
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104378
Employment Type: Full-Time
Shift Schedule: Tuesday to Saturday | 3:00 PM – 12:00 AM (IST)
Job Summary
Syneos Health®, a global biopharmaceutical solutions organization, is hiring a Safety & Pharmacovigilance Specialist I – Mandarin/Chinese Speaker to support global clinical trial and post-marketing safety operations. This role focuses on ICSR processing, safety data management, regulatory compliance, and Mandarin/Chinese medical translation within a global pharmacovigilance environment.
This position is well-suited for entry-level professionals and fresh science graduates seeking a career in Drug Safety, Pharmacovigilance, and Regulatory Affairs.
Key Responsibilities
Receive, track, and process Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and safety databases
Perform ICSR triage and evaluate cases for completeness, accuracy, and regulatory reportability
Enter and code adverse events, medical history, concomitant medications, laboratory tests, and indications using MedDRA and WHO Drug dictionaries
Prepare clear, compliant case narratives and manage follow-ups to resolve data queries
Support the timely preparation and submission of expedited safety reports in accordance with global regulatory timelines
Maintain safety tracking logs for assigned activities
Conduct literature screening and safety reviews
Perform xEVMPD validation and submissions, including MedDRA-based indication coding
Support SPOR and IDMP-related activities
Identify and manage duplicate safety cases
Perform quality review of ICSRs to ensure regulatory compliance
Ensure accurate filing of safety documentation in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP, and global regulatory requirements
Participate in internal audits, inspections, and quality initiatives as required
Collaborate effectively with cross-functional and global stakeholders
Education and Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline
0–1 year of experience in Pharmacovigilance, Drug Safety, Clinical Research, or related domains
Freshers and entry-level candidates are encouraged to apply
Prior exposure to ICSR processing or safety databases is preferred but not mandatory
Language Requirements
Mandarin/Chinese proficiency:
Minimum HSK Level 4
HSK Level 5 or above preferred
Strong translation and written communication skills
Conversational spoken Mandarin/Chinese proficiency acceptable
Technical and Professional Skills
Knowledge of pharmacovigilance processes and medical terminology
Understanding of clinical trial phases (II–IV) and/or post-marketing safety requirements
Familiarity with ICH-GCP, GVP, and global drug safety regulations
Proficiency in MS Word, Excel, PowerPoint, Outlook, and internet-based tools
High attention to detail with strong accuracy and time management skills
Ability to work independently and within a global team environment
Strong communication, organizational, and interpersonal skills
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization operating across more than 110 countries. Over the past five years, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, delivering more than 200 studies across 73,000 sites globally.
Additional Information
Job responsibilities may evolve based on business requirements
Equivalent education, skills, or experience may be considered
This job description does not constitute an employment contract
Syneos Health is an equal opportunity employer and complies with all applicable employment laws
SEO & Search Optimization Keywords
Pharmacovigilance Jobs in India, Drug Safety Specialist, Safety & PV Specialist, Mandarin Pharmacovigilance Jobs, Entry Level Pharmacovigilance, ICSR Processing, Clinical Safety Jobs Pune, CRO Drug Safety Careers, MedDRA Coding, xEVMPD, GVP Compliance
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