Safety & PV Specialist I (Japanese Language Expert)

Syneos Health

1 - 3 years

3 - 15 Lacs

gurgaon haryana india

Posted:3 days ago| Platform: Foundit logo

Apply

Skills Required

pharmacovigilance data analysis risk assessment report writing japanese language sop

Work Mode

On-site

Job Type

Full Time

Job Description

Job Responsibilities

Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Assist in the processing of ICSRs as per Standard Operating Procedures (SOPs) and project/program-specific safety plans.
Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability.
Enter data into safety database.
Code events, medical history, concomitant medications, and tests.
Compile complete narrative summaries.
Identify missing information, raise queries, and follow up until resolution.
Generate timely, consistent, and accurate expedited reports per regulatory requirements.
Maintain safety tracking for assigned activities.
Perform literature screening and review for safety, drug coding, and MedDRA coding.
Validate and submit xEVMPD product records, including indication coding using MedDRA.
Perform manual recoding of un-recoded product and substance terms from ICSRs.
Identify and manage duplicate ICSRs.
Handle activities related to SPOR/IDMP.
Conduct quality review of ICSRs.
Ensure submission of relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File as per SOP/Sponsor requirements.
Maintain compliance with SOPs, Work Instructions (WIs), global regulations, GCP, ICH, and GVP guidelines.
Foster constructive and professional relationships with project team members, internal and external.
Participate in audits as required.
Apply safety reporting regulatory intelligence maintained by Syneos Health to safety reporting activities.

Qualifications

Master's in Pharmacy (preferred) or Master's in Science/Healthcare field, or equivalent combination of education and experience.
Excellent interpersonal and communication skills.
Advanced skills in Microsoft Office applications.

More Jobs at Syneos Health

Intern

Greater Madurai Area

Experience: Not specified

Salary: Not disclosed

Regulatory / Sr Regulatory Associate (Module 1, regulatory submission)

Greater Madurai Area

5 - 8 yrs

Salary: Not disclosed

Regulatory / Sr Regulatory Associate (Module 1, regulatory submission)

Greater Kolkata Area

5 - 8 yrs

Salary: Not disclosed

IMS Specialist II (Customer Support)

Gurugram, Haryana, India

Experience: Not specified

Salary: Not disclosed

Sr Clinical Programmer (Spotfire/Cluepoints Prog)

Greater Kolkata Area

5 - 5 yrs

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.