Safety & PV Specialist II - Japanese Language

Safety & PV Specialist II - Japanese Language

inVentiv Health Clinical SRE, LLC
Not Specified
Not Specified

Job Description


Job Description :
Safety & Pharmacovigilance Specialist II
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
. #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
. 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 - we're able to create a place where everyone feels like they belong.
Job responsibilities
. Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
. May assist in the preparation of the Safety Management Plan
. Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
o Enters data into safety database.
o Codes events, medical history, concomitant medications and tests.
o Compiles complete narrative summaries.
o Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
o Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.
. 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, GCPs, ICH guidelines, GVP, project/program plans and the drug development process. Qualifications
  • The candidate must be certified in Japanese Language Proficiency Test (JLPT). Candidates with JLPT Level 1 to 5 will be eligible.
  • Person should know to read and write Japanese (Mandatory)
  • 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)

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