Safety & PV Specialist I

Safety & PV Specialist I

inVentiv Health Clinical SRE, LLC
Not Specified
Not Specified

Job Description

Job Description :
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
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 postmarketing
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
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

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