Description
Safety & PV Specialist I (Japanese Language)
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Review safety case information in the Argus database, ensuring consistency between English source data and Japanese entries, and translate relevant data into accurate high-quality Japanese for regulatory-compliant reporting.
Prepare and write Japanese narratives for Japan's specific cases as required.
Handle Japan domestic safety cases including data entry from Japanese source documents, in compliance with Japan- specific reporting standards.
Perform work primarily focused on reading and writing Japanese including medical narrators unstructured database fields with minimal speaking requirements.
Demonstrate strong Japanese language proficiency advance kanji knowledge and the ability to accurately interpret clinical and safety information
Background or working knowledge in pharmacovigilance, drug safety, or medical/life sciences field will be considered an added advantage.
Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
Maintains safety tracking for assigned activities.
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
Manual recoding of un-recoded product and substance terms arises from ICSRs.
Identification and management of duplicate ICSRs.
Activities related to SPOR / IDMP.
Quality review of ICSRs.
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, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
Fosters constructive and professional working relationships with all project team members, internal and external.
Participates in audits as required/appropriate.
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Qualifications:
Mandatory to have JLPT N3 certification, JLPT N2 certification preferred
Candidates with PV experience are preferred
Bachelor’s Degree in life science/ Non-life science background and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
Safety Database systems and knowledge of medical terminology required.
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
Ability to work independently and in a team environment.
Excellent communication and interpersonal skills, both written and spoken.
Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
Detail oriented with a high degree of accuracy and ability to meet deadlines.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Pharmacovigilance & Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.
