Job Summary:
Syneos Health is seeking a Safety & PV Specialist I (Japanese Language Expert) for its Gurgaon location. This role requires expertise in pharmacovigilance operations, including ICSR processing, safety data entry, MedDRA coding, and regulatory reporting activities. Candidates must possess proficiency in the Japanese language to manage global safety information efficiently and ensure compliance with international drug safety guidelines.
Key Responsibilities:
Enter ICSR information into PVG quality and tracking systems.
Process and evaluate ICSRs for completeness, accuracy, and regulatory compliance.
Perform MedDRA coding for events, medical history, and drug data.
Prepare comprehensive narrative summaries and query for missing information.
Support expedited report generation as per regulatory timelines.
Conduct literature screening and MedDRA maintenance activities.
Validate and submit xEVMPD product records, coding using MedDRA.
Manage duplicate ICSR identification and resolution.
Maintain regulatory intelligence on global drug safety requirements.
Participate in audits and quality review of ICSRs.
Ensure timely documentation submission for TMF and PV system files.
Collaborate professionally with internal and external teams.
Remain updated on SOPs, global PV guidelines (GVP, ICH-GCP), and sponsor requirements.
Required Skills & Qualifications:
Fluency in Japanese (reading and writing essential).
Prior experience in Pharmacovigilance, PVG systems, or drug safety desirable.
Knowledge of ICSR processing and MedDRA coding preferred.
Understanding of GCP, ICH, and GVP guidelines.
Familiarity with regulatory submissions and drug safety reporting.
Excellent communication and organizational skills.
Ability to handle global drug safety documentation accurately.
Perks & Benefits:
Global exposure to pharmacovigilance processes.
Career progression and technical skill enhancement.
Supportive management and peer recognition programs.
Involvement in industry-leading clinical development projects.
Company Description:
Syneos Health® is a global leader in fully integrated biopharmaceutical solutions, serving clients across more than 110 countries. The organization focuses on advancing clinical research, drug safety, and regulatory services to enhance patient outcomes worldwide.
Work Mode:
On-site – Gurgaon, India
Call-to-Action:
Interested in shaping the future of global drug safety? Apply now to join Syneos Health as a Safety & PV Specialist I and contribute your Japanese language expertise to pharmacovigilance excellence.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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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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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Mississauga | Renfrew | Richmond Hill | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
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Khulais | Riyadh | Jeddah | Najran | King Abdullah Economic City | 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 :
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