Safety and Pharmacovigilance Specialist I (Japanese Language)
Location: Hyderabad, India
Job ID: 25104312
Company: Syneos Health
Industry: Pharmacovigilance / Drug Safety / Clinical Research
Employment Type: Full-Time
Experience Required: 0–2 Years (Pharmacovigilance or Drug Safety Experience Preferred)
Updated: January 29, 2026
Job Overview
Syneos Health is hiring a Safety and Pharmacovigilance Specialist I with Japanese language expertise to support global drug safety operations, regulatory compliance, and pharmacovigilance reporting. The role involves processing Individual Case Safety Reports (ICSRs), preparing Japanese safety narratives, reviewing safety databases, and ensuring compliance with global and Japan-specific regulatory requirements.
This opportunity is ideal for candidates with strong Japanese language proficiency, knowledge of medical terminology, and interest or experience in pharmacovigilance, clinical trials, or life sciences. The position contributes to safety monitoring, regulatory reporting, and clinical data management within a global biopharmaceutical environment.
Syneos Health is a leading global biopharmaceutical solutions organization focused on accelerating clinical development and delivering therapies that improve patient outcomes worldwide.
Key Responsibilities
Review safety case information in Argus safety database and ensure consistency between English source data and Japanese entries
Translate clinical and safety data into accurate, high-quality Japanese for regulatory-compliant reporting
Prepare Japanese safety narratives for Japan-specific pharmacovigilance cases
Process Japan domestic safety cases and perform data entry from Japanese source documents according to regulatory standards
Handle medical narrative documentation within structured and unstructured safety database fields
Assist in processing Individual Case Safety Reports (ICSRs) in compliance with standard operating procedures and safety plans
Perform case triage and evaluate safety data for completeness, accuracy, and reportability
Enter data into safety databases and code adverse events, medical history, medications, and laboratory results
Compile narrative summaries and follow up on missing or unclear safety information
Support generation of timely and accurate expedited safety reports
Maintain safety tracking systems for assigned pharmacovigilance activities
Perform literature screening and review for drug safety monitoring
Conduct MedDRA coding and maintain drug safety dictionaries
Validate and submit xEVMPD product records with appropriate coding of indication terms
Identify and manage duplicate ICSRs and perform manual data recoding when required
Support SPOR and IDMP regulatory activities
Conduct quality review of safety cases and documentation
Ensure submission of required documentation to Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with global pharmacovigilance regulations, GCP, ICH guidelines, and GVP standards
Participate in audits, inspections, and quality assurance activities
Collaborate with internal and external project teams to support safety reporting operations
Eligibility Criteria and Qualifications
Bachelor’s degree in Life Sciences or relevant field; equivalent experience may be considered
Mandatory JLPT N3 certification; JLPT N2 certification preferred
0–2 years of experience in pharmacovigilance, drug safety, or related healthcare domain preferred
Strong Japanese reading and writing proficiency with advanced Kanji knowledge
Knowledge of safety database systems and medical terminology
Understanding of clinical trial processes (Phases II–IV) and post-marketing safety requirements
Familiarity with ICH GCP, GVP, and global pharmacovigilance regulations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, and collaboration tools
Strong analytical and problem-solving skills
Excellent communication and interpersonal abilities
High attention to detail and accuracy in documentation
Ability to manage multiple tasks and meet strict timelines
Ability to work independently and collaboratively in a team environment
Preferred Skills
Prior experience in pharmacovigilance operations or drug safety reporting
Experience with safety databases such as Argus
Knowledge of MedDRA coding and regulatory reporting standards
Understanding of drug development lifecycle and regulatory compliance processes
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization with over 29,000 employees across 110 countries. The organization combines clinical development, medical affairs, and commercial expertise to accelerate therapy delivery and improve patient outcomes. Over the past five years, Syneos Health has supported 94 percent of novel FDA-approved drugs and 95 percent of EMA-authorized products, contributing to more than 200 studies across 73,000 sites and over 675,000 clinical trial participants globally.
The company fosters professional development, innovation, diversity, and a collaborative work environment focused on advancing global healthcare.
Gujarat :
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Seoul |Kazakhstan :
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New Mexico | Ciudad de México |Dubai :
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Najran | Riyadh | King Abdullah Economic City | Khulais | Jeddah | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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