Syneos Health® Hiring Safety & PV Specialist (Japanese Language Translator) in India

Syneos Health® is Hiring! Join the Team as Safety & PV Specialist I (Japanese Language Translator) in India

About Syneos Health®

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. We are continuously looking for ways to simplify and streamline our work to make us easier to work for and with.

Current Vacancies

We are currently hiring for the position of Safety & Pharmacovigilance Specialist I (Japanese Language Translator). This role provides an exceptional opportunity for professionals looking to advance their career in the pharmaceutical industry.

Job Description and Responsibilities

As a Safety & Pharmacovigilance Specialist I, your responsibilities will include:

1. Entering information into PVG quality and tracking systems for receipt and tracking ICSR.
2. Performing set-up, delivery, and close-out of safety and pharmacovigilance projects.
3. Processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
4. Triaging ICSRs, evaluating ICSR data for completeness, accuracy, and regulatory reportability.
5. Entering data into the safety database.
6. Coding events, medical history, concomitant medications, and tests.
7. Compiling complete narrative summaries.
8. Assessing information to be queried and following up until information is obtained and queries are satisfactorily resolved.
9. Participating in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
10. Coordinating with data management staff concerning reconciliation of safety data between the clinical and safety databases.
11. Maintaining safety tracking for assigned activities.
12. Performing literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.
13. Validating and Submitting xEVMPD product records, including appropriate coding of indication terms using MedDRA.
14. Identifying and managing duplicate ICSRs.
15. Performing activities related to SPOR / IDMP.
16. Quality reviewing of ICSRs.
17. Serving as a subject matter expert in SPVG, including resolution of project-related routine queries and mentoring, coaching, and training of new hires.
18. Representing the company during audits/inspections.
19. Ensuring 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.

Role: Safety & PV Specialist I (Japanese Language Translator)
Industry Type: Biopharmaceuticals
Employment Type: Full Time
Job Location: India-Asia Pacific – IND-Home-Based, India

Qualifications and Requirements

• The candidate must be certified in Japanese Language Proficiency Test (JLPT). Candidates with JLPT Level 2 to 1 will be eligible.
• The person should know to speak, read, and write Japanese. This is mandatory.
• The candidate should have completed Graduation in any domain.
• Having working experience in Pharmacovigilance or Clinical Research domain is an added advantage.
• Having working experience in J-E, or E-J translator or interpretation can also be an added advantage.

How to Apply

Interested candidates are encouraged to apply Here