Applicant Must work from Hyd & Blr

Updated: December 15, 2022
Location: India-Asia Pacific – IND-Kinapse-Bengalaru
Job ID: 22011397

Description

Safety & Pharmacovigilance Specialist I

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 report ability.
     o    Enters data into 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

Must have minimum 2yrs of Data Entry Experience

•    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
•    Good 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

Apply : https://www.syneoshealth.com/clinical-corporate-careers/jobs/11560477-safety-and-pv-specialist-i-2-plus-yrs-in-icdr-de-plus-applicant-must-work-from-hyd-and-blr