Syneos Health Clinical Solutions jobs - Glbl Safety PV Associate

Glbl Safety PV Associate

Syneos Health Clinical Solutions

Pune

0 to3 Years

Salary not disclosed

Certificate Course (ITI), Diploma, M Phil / Phd, B.Com, M.Com, MA, BBA/BBM, BCA, BEd, BSc, MCA, MEd, MSc, PG Diploma, Vocational Training, BFA, BSW

Job Description

Complete data entry in safety database including writing of adverse event narrative and preliminary assessment of event seriousness and expectedness / listedness as per Reference Safety Information. Documents will be in Japanese Language

Generate adverse event queries, liaise with the medical reviewers and clients to agree upon the queries, and send request for additional information to the sites/reporter.

Engage with the Site Monitors to ensure follow up information is obtained from site effectively.

Forward safety report documents to designated medical reviewer for review.

Forward completed safety report documents to clients and other relevant parties.

Foster constructive and professional working relationships with all project team members, internal and external.

File documents according to project specific requirements (electronically or in hard copy as applicable).

Ensure case files are compliant with SOPs.

Interact and communicate effectively with other company departments/functions such as project management field monitoring, data management, etc. to ensure the highest level of client satisfaction through successful execution of projects.

Perform literature review as appropriate for Post-Marketing cases.

Maintain knowledge of legislation, guidelines and regulations relating to safety and PV reporting applicable to countries where Syneoes Health Clinical manages safety responsibilities.

Provide support for PV Lead with miscellaneous project tasks relating to safety reporting.

Participate in audits as required/appropriate.

Any other duties as assigned by manager

Bachelorâs 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.

The candidate must be certified in Japanese Language Proficiency Test (JLPT). Candidates with JLPT N4 or N3 certification 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

Applicant should be ready to work in Japanese time zone

Safety Database systems and knowledge of medical terminology preferred.

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

Good communication and interpersonal skills, both written and spoken

Primary Location

Asia Pacific - IND-Pune-Yerwada-Jail-Rd

Other Locations

Asia Pacific - IND-Hyderabad-Madhapur-Village

Job

Safety & Pharmaco

Schedule

Full-time

Travel

No

Employee Status

Regular