Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 1K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

For Employers

Add office photos

Employer? Claim Account for FREE

Syneos Health

Compare

3.9

based on 556 Reviews

1 Syneos Health Chinese Language Expert Job

Chinese Language Expert - Safety & PV Specialist I

inVentiv International Pharma Services Pvt. Ltd

3.9

based on 556 Reviews

2-6 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Chinese Language Expert - Safety & PV Specialist I

Syneos Health

posted 5d ago

Job Role Insights

Flexible timing

Key skills for the job

Medical Coding Supervision Pharmacovigilance Clinical Data Management Recruitment GCP

+ 3 more

Job Description

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 - 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 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.

Qualifications

What we re looking for

Bachelor s Degree in life science, registered nurse, pharmacist or an equivalent combination of education 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), TeamShare (or other 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.
Minimal travel may be required (up to 5%).

Employment Type: Full Time, Permanent

Read full job description

Prepare for Chinese Language Expert roles with real interview advice