Safety and Pharmacovigilance Specialist I (Japanese Language) at Syneos Health
Safety and Pharmacovigilance Specialist I (Japanese Language) at Syneos Health
Syneos Health is seeking a Safety and Pharmacovigilance Specialist I with certification in the Japanese Language Proficiency Test (JLPT) for their India-Asia Pacific location. The position involves entering information into PVG quality and tracking systems, processing ICSRs according to Standard Operating Procedures (SOPs), and ensuring compliance with global drug/biologic/device regulations, GCPs, ICH guidelines, and GVP. The candidate must have a good grasp of medical terminology and computer proficiency with Microsoft Office Suite. Additionally, the role requires the candidate to translate/interpret information from Japanese to English and vice versa for teams
Safety & PV Specialist I – Japanese Language
Updated: Today
Location: India-Asia Pacific – IND-Home-Based
Job ID: 23003194
Description
Safety & Pharmacovigilance Specialist I
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.
Discover what our 29,000 employees across 110 countries already know:
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
- Assists in processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
- Triages ICSRs, and evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into the safety database.
- Codes events, medical history, concomitant medications, and tests.
- Compiles complete narrative summaries.
- Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Assists in generating timely, consistent, and accurate reporting expedited reports by applicable regulatory requirements.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
- Maintains Understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans, and the drug development process.
Qualifications
Qualifications:
- The candidate must be certified in the Japanese Language Proficiency Test (JLPT). Candidates with JLPT Level 3 to 1 will be eligible.
- The person should know to read and write Japanese (Mandatory)
- The role requires the candidate to translate/interpret information from Japanese to English and English to Japanese for teams.
- Candidate must have a good grasp of the Japanese language
- I preferred having a Good Understanding of medical terminology.
- Computer proficiency, including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS Powerpoint), email software (Outlook), and spreadsheet software (MS Excel)
