Glbl Safety & PV Associate II

Glbl Safety & PV Associate II

inVentiv Health Clinical SRE, LLC
China
Not Specified
Not Specified

Job Description


Job Description :
Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
May assist in the preparation of the Safety Management Plan
Processes 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 Assesses information to be queried and follows up until information is obtained and queries
are satisfactorily resolved.
o Participates in the generation of timely, consistent and accurate reporting of expedited
reports in accordance with applicable regulatory requirements.
o Coordinates with data management staff concerning reconciliation of safety data between the
clinical and safety databases.
Ensures distribution of all required individual expedited and periodic reports for both clinical and postmarketing
projects to the Safety Submissions team if contracted to submit the reports.
Participate in audits/inspections as required
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
Minimal travel may be required (up to 5%)

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