Safety & PV Specialist I - Japanese Language expert

Syneos Health is seeking a Safety & PV Specialist I - Japanese Language expert. As a Safety & PV Specialist, you will play a critical role in ensuring the safety of pharmaceutical products.

Job Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs) as required.
• Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
• Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability.
• Enter data into safety database, code events, medical history, concomitant medications, and tests.
• Compile complete narrative summaries and identify information to be queried.
• Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintain safety tracking for assigned activities.
• Perform literature screening and review for safety, drug coding, and maintenance of drug dictionary.
• Validate and submit xEVMPD product records, including coding of indication terms using MedDRA.
• Participate in activities related to SPOR / IDMP and quality review of ICSRs.

Qualifications

• Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience.
• At least JLPT N3 Certification in Japanese language.
• Knowledge of safety database systems and medical terminology required.
• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share, and internet.
• Ability to work independently and in a team environment with excellent communication and interpersonal skills.

What We Offer

Syneos Health offers a dynamic work environment with opportunities for career growth and development. The company is committed to building an inclusive culture where employees can authentically be themselves.