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Syneos BSc Job Opening – Safety & PV Specialist
Syneos BSc Job Opening – Safety & PV Specialist. Syneos Health Safety & PV Specialist I vacancy available. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Safety & PV Specialist I-Gurgaon
Location – India-Asia Pacific – IND-Gurugram-PresidencyTwrsMGr
Job ID – 22010206
Description
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
- Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
o Enters data into the safety database.
o Codes events, medical history, concomitant medications and tests.
o Compiles complete narrative summaries.
o Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
o Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. - 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, GCPs, 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.
- 2+ years of working experience in ICSR Data Entry
- Should have worked on Argus Database
- Should be from Delhi/Gurgaon nearby cities only
- Fulltime Working from office and no vacancy for Homebased
- 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 the internet.
- Ability to work independently and in a team environment
- Good communication and interpersonal skills, both written and spoken
- Good organizational skills with a proven ability to prioritize and work on multiple tasks and projects.
- Detail-oriented with a high degree of accuracy and ability to meet deadlines.
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