Safety and Pharmacovigilance Specialist I (Japanese Language)
Location: Gurugram, 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 seeking a Safety and Pharmacovigilance Specialist I with Japanese language expertise to support global drug safety operations, regulatory compliance, and pharmacovigilance reporting processes. The role involves reviewing safety cases, preparing Japanese medical narratives, processing Individual Case Safety Reports (ICSRs), and ensuring compliance with global and Japan-specific regulatory requirements.
This position is suitable for candidates with strong Japanese language proficiency, knowledge of medical terminology, and interest or experience in pharmacovigilance, clinical research, or life sciences. The role plays a critical part in maintaining patient safety, regulatory compliance, and clinical data integrity within a global biopharmaceutical environment.
Syneos Health is a leading integrated biopharmaceutical solutions organization dedicated to accelerating therapy development and improving patient outcomes worldwide.
Key Responsibilities
Review safety case information in the Argus safety database and ensure consistency between English source data and Japanese entries
Translate clinical and safety data into accurate Japanese for regulatory-compliant reporting
Prepare and author Japanese safety narratives for Japan-specific cases
Process Japan domestic safety cases and perform data entry from Japanese source documents in compliance with local regulatory standards
Manage medical narrative documentation within structured and unstructured database fields
Assist in processing Individual Case Safety Reports (ICSRs) according to standard operating procedures and project-specific safety plans
Perform case triage and evaluate safety data for completeness, accuracy, and regulatory reportability
Enter and code adverse events, medical history, concomitant medications, and laboratory data in safety databases
Compile narrative summaries and follow up on missing or unclear information
Support timely and accurate expedited safety reporting
Maintain safety tracking systems for assigned pharmacovigilance activities
Conduct literature screening and safety monitoring activities
Perform MedDRA coding and maintain drug safety dictionaries
Validate and submit xEVMPD product records and ensure accurate coding of indication terms
Identify and manage duplicate ICSRs and perform manual data recoding when required
Support SPOR and IDMP regulatory activities
Perform quality review of safety cases and documentation
Ensure submission of relevant documents 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 cross-functional teams to support global safety reporting processes
Eligibility Criteria and Qualifications
Bachelor’s degree in Life Sciences or related discipline; 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 tools including Word, Excel, and PowerPoint
Strong analytical, organizational, and problem-solving skills
Excellent communication and interpersonal abilities
High attention to detail and accuracy in documentation
Ability to manage multiple priorities and meet deadlines
Capability to work independently and collaboratively within global teams
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 more than 29,000 employees across 110 countries. The company 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 over 200 studies across 73,000 sites and more than 675,000 clinical trial participants globally.
Syneos Health promotes professional development, innovation, diversity, and a collaborative work environment dedicated to advancing global healthcare.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Andra Pradesh :
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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 |Madhya Pradesh :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Peru | Argentina |Brazil :
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Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Jeddah | Riyadh | King Abdullah Economic City | Najran | Khulais | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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