Safety & Pharmacovigilance Specialist I – Mandarin/Chinese Speaker
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104378
Employment Type: Full-Time
Shift: Tuesday to Saturday | 3:00 PM – 12:00 AM (IST)
Job Overview
Syneos Health®, a leading global biopharmaceutical solutions organization, is seeking a Safety & Pharmacovigilance (PV) Specialist I – Mandarin/Chinese Speaker to join its Pharmacovigilance and Drug Safety team in Pune, India. This entry-level role supports global clinical trial and post-marketing safety operations, with a strong focus on Individual Case Safety Report (ICSR) processing, regulatory compliance, and Mandarin/Chinese medical translation.
This position is ideal for science graduates and early-career professionals aiming to build a long-term career in Pharmacovigilance, Drug Safety, and Regulatory Affairs within a global CRO environment.
Key Responsibilities
Process and track Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and safety databases in accordance with SOPs and project-specific safety plans
Perform ICSR triage, assess case completeness, accuracy, and regulatory reportability
Enter, code, and review adverse events, medical history, concomitant medications, and laboratory data using MedDRA and WHO Drug dictionaries
Compile clear and compliant case narratives and identify missing information; perform follow-ups until resolution
Support the preparation and submission of expedited safety reports in line with global regulatory timelines
Conduct literature screening and review for safety-relevant information
Perform activities related to xEVMPD submissions, SPOR/IDMP compliance, and manual recoding of products and substances
Identify and manage duplicate ICSRs
Conduct quality review of safety cases and ensure accurate documentation
Ensure submission of all required documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with ICH-GCP, GVP, global regulatory requirements, and Syneos Health SOPs
Participate in audits, inspections, and internal quality initiatives as required
Collaborate effectively with cross-functional global teams and stakeholders
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline
Equivalent combination of education and relevant experience will be considered
Experience
0–1 year of experience in Pharmacovigilance, Drug Safety, or Clinical Research
Freshers and entry-level candidates are welcome
Prior exposure to ICSR processing or safety databases is an advantage but not mandatory
Language Requirements
Mandarin/Chinese proficiency:
HSK Level 4 minimum
HSK Level 5 or higher preferred
Translation skills: Critical and essential
Writing: Strong proficiency required
Speaking: Conversational proficiency acceptable
Technical & Professional Skills
Basic 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-based tools
Strong attention to detail, accuracy, and ability to meet strict timelines
Excellent communication, organizational, and interpersonal skills
Ability to work independently as well as in a global team environment
Why Join Syneos Health
Work with a global leader involved in 94% of novel FDA-approved drugs and 95% of EMA-authorized products
Exposure to large-scale global clinical trials and post-marketing safety programs
Strong focus on career development, training, and internal mobility
Inclusive workplace culture that values diversity, collaboration, and professional growth
Additional Information
Job responsibilities may evolve based on business needs
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 labor and employment laws
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization, operating across more than 110 countries. The company partners with customers to accelerate the delivery of therapies through innovative clinical development, medical affairs, and commercial solutions.
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