Syneos Health has announced an opening for Safety & PV Specialist I – Japanese Language Expert in Gurugram, India. This opportunity is suitable for candidates with a life sciences, pharmacy, nursing, or related educational background who have knowledge of pharmacovigilance, ICSR processing, safety databases, MedDRA coding, clinical trials, and drug safety regulations.
A key requirement for this Syneos Health pharmacovigilance job is JLPT N3 certification or above. Selected professionals will support individual case safety report (ICSR) processing, safety database activities, literature screening, regulatory reporting, coding, quality review, and other global pharmacovigilance activities.
Syneos Health Safety & PV Specialist I – Job Overview
| Particulars | Details |
|---|---|
| Company | Syneos Health |
| Position | Safety & PV Specialist I – Japanese Language Expert |
| Job ID | 25104761 |
| Location | Gurugram, India |
| Work Type | Full-Time |
| Work Arrangement | Remote (Exception) |
| Department | Safety / Pharmacovigilance |
| Qualification | Bachelor’s Degree in Life Sciences, Pharmacy, Nursing or equivalent |
| Language Requirement | JLPT N3 Certification or above |
| Experience | Relevant PV/safety knowledge or equivalent experience |
| Estimated Salary | ₹4.5–8 LPA* |
*Salary is an editorial estimate for informational purposes only. Syneos Health has not specified compensation in the provided job posting. Actual salary may vary according to experience, skills and company policy.
Key Responsibilities
As a Safety & PV Specialist I at Syneos Health, the selected candidate may be responsible for:
- Receiving, tracking, triaging and processing Individual Case Safety Reports (ICSRs) according to applicable SOPs and safety plans.
- Reviewing ICSR information for completeness, accuracy and regulatory reportability.
- Entering adverse event and safety information into pharmacovigilance safety databases.
- Coding adverse events, medical history, concomitant medications and relevant tests.
- Preparing complete and accurate safety narrative summaries.
- Identifying missing information and managing follow-up queries.
- Supporting timely expedited safety reporting according to applicable regulatory requirements.
- Maintaining safety tracking systems for assigned pharmacovigilance activities.
- Performing literature screening and safety literature review.
- Supporting drug coding, drug dictionary maintenance and MedDRA coding.
- Validating and submitting xEVMPD product records.
- Performing manual recoding of product and substance terms arising from ICSRs.
- Identifying and managing duplicate ICSRs.
- Supporting SPOR and IDMP-related activities.
- Conducting quality reviews of ICSRs.
- Ensuring relevant documentation is submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File, as applicable.
- Maintaining compliance with SOPs, work instructions, GCP, ICH guidelines, GVP and applicable global safety regulations.
- Participating in audits when required.
- Applying regulatory intelligence to safety reporting activities.
Who Can Apply?
Candidates should have a Bachelor’s degree in Life Sciences, be a registered nurse, pharmacist, or possess an equivalent combination of education and experience that provides the required knowledge and skills.
Relevant educational backgrounds may include B.Pharm, M.Pharm, Pharm.D, B.Sc/M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Nursing, Clinical Research or other closely related life science disciplines, subject to Syneos Health’s eligibility assessment.
Most importantly, candidates should hold at least JLPT N3 certification in Japanese.
Skills Required
Applicants should have knowledge or experience in:
- Pharmacovigilance and drug safety
- ICSR processing and case management
- Safety database systems
- Medical terminology
- MedDRA coding
- Literature screening
- Clinical trial processes
- Phase II–IV clinical trials and/or post-marketing safety
- ICH-GCP and Good Pharmacovigilance Practices (GVP)
- Safety reporting regulations
- Microsoft Word, Excel and PowerPoint
- Outlook and shared content/workspace platforms
- Strong written and verbal communication
- Time management and organizational skills
- Attention to detail and accuracy
Why Consider This Syneos Health PV Job?
Syneos Health operates across clinical development and commercialization services, providing employees with exposure to global drug development and pharmacovigilance activities.
The company highlights career development, technical and therapeutic-area training, supportive management, peer recognition and total rewards programs as part of its employee offering.
For candidates looking to develop a career in drug safety and pharmacovigilance, this Safety & PV Specialist I role provides exposure to ICSR processing, safety databases, regulatory reporting, MedDRA, xEVMPD, SPOR/IDMP and global PV regulations.
How to Apply
