Life Sciences Job at Syneos Health | Safety & PV Specialist | Apply Now
Syneos Health, a global leader in biopharmaceutical solutions, is currently hiring for the position of Safety & PV Specialist I – Mandarin/Chinese Speaker in Pune. This Life Sciences job is a specialized role within the Pharmacovigilance (PV) sector, requiring a unique blend of medical knowledge and linguistic expertise to support global drug safety operations. A Syneos Health career offers the opportunity to work with an organization that has contributed to 94% of all novel FDA-approved drugs in recent years. This role is essential for ensuring that Individual Case Safety Reports (ICSRs) from Chinese-speaking regions are accurately processed and reported to global regulatory authorities.
- Job Role: Safety & PV Specialist I – Mandarin/Chinese Speaker
- Location: Pune, Maharashtra, India
About the Company
Syneos Health is a fully integrated biopharmaceutical solutions organization that combines Clinical Development and Commercial insights. With 29,000 employees across 110 countries, the company operates in both Functional Service Provider (FSP) and Full-Service environments, focusing on accelerating the delivery of life-changing therapies.
Job Overview
This position involves the end-to-end processing of drug safety data. The specialist acts as a technical gatekeeper, ensuring that every adverse event reported is documented with clinical precision and translated accurately from Mandarin to English for regulatory submission.
Key Responsibilities:
- ICSR Management: Triage, receipt, and tracking of Individual Case Safety Reports (ICSRs). You will evaluate data for completeness and accuracy before entry into the safety database.
- Medical Coding: Use standardized dictionaries like MedDRA for events and medical history, and WHODrug for concomitant medications.
- Narrative Writing: Compile complete and concise medical narrative summaries of adverse events.
- Literature Screening: Perform screening of scientific literature for safety signals and maintain drug dictionaries.
- Regulatory Compliance: Assist in the timely generation of expedited reports in accordance with GCP, ICH, and GVP guidelines.
- Technical Maintenance: Activities related to SPOR / IDMP and the validation of xEVMPD product records.
Qualifications & Requirements
To excel in this Life Sciences job, candidates must meet the following criteria:
- Education: Bachelor’s degree in Life Sciences. Science graduates are preferred, and freshers are welcome to apply.
- Linguistic Skills: * Mandarin: Minimum HSK 4 certification; HSK 5 or 6 is highly preferred.
- Translation: High importance placed on the ability to translate technical medical data.
- Technical Skills: Proficiency in MS Office and familiarity with safety databases. Understanding of clinical trial phases (II-IV) is a plus.
- Shift Details: Tuesday to Saturday, 3 PM – 12 AM (Night Shift).
Applying for a Life Sciences job at Syneos Health is a strategic move for bilingual professionals seeking to enter the high-growth field of Pharmacovigilance. This role bridges the gap between clinical data and global regulatory safety standards, making it a cornerstone of a successful Syneos Health career. If you have a background in Pharmacy or Life Sciences and hold an HSK 4+ certification in Mandarin, this is your chance to contribute to global patient safety from Pune.
