SAFETY & PV SPECIALIST II – JAPANESE LANGUAGE EXPERT From 0 to 3 year(s) of experience-Remote (Hiring office located in Delhi / NCR)
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 our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong.
QUALIFICATION REQUIREMENTS
The candidate must be certified in Japanese Language Proficiency Test (JLPT). Candidates with JLPT Level 3 to 1 will be eligible.
Person should know to Speak, read and write Japanese (Mandatory)
Should have completed Graduation from any Life science, Medical Science , Bioscience or Pharmacy related qualifications
Having working experience in Pharmacovigilance or Clinical Research domain is added advantage
Havin working experience in J-E, or E-J translator or interpretation can be added advantage
Role requires the candidate to translate/interpret information from Japanese to English and English to Japanese for teams
Candidate must have a good grasp over Japanese language
Preferred having Good Understanding in medical terminology
Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS Power rpoint), email software (Outlook), and spreadsheet software (MS Excel)
Job responsibilities
Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.
May assist in the preparation of the project plans such as Safety Management Plan.
May perform set-up, delivery and close-out of safety and pharmacovigilance projects.
Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
Enters data into safety database.
Codes events, medical history, concomitant medications and tests.
Compiles complete narrative summaries.
Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.
Maintains safety tracking for assigned activities.
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and 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.
Quality review for the work performed by peers.
Serves as a subject matter expert in SPVG, which includes resolution of project related routine queries; mentoring, coaching and training of new hires.
Fosters constructive and professional working relationships with all project team members, internal and external.
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
Participate in audits/inspections as required.
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.
Disclaimer:
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.
Education
UG:B.Pharma in Any Specialization,B.Sc in Any Specialization
PG:M.Pharma in Any Specialization,MS/M.Sc(Science) in Any Specialization
