PV Associate/Literature

POSITION SUMMARY

PV associate in literature must participate in Global Literature Screening process, by providing review and assessment of the scientific and medical literature, according to procedures and regulatory requirements.

CORE RESPONSIBILITIES

• · To participate in weekly and ad hoc literature searches
• · To participate in weekly and ad hoc literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to nominated products for use in signal detection and aggregate reports, and document the process in literature screening tracker
• · To plan and conduct the review of literature references
• · To order copies of full literature articles for review
• · To order translation of literature reference if applicable
• · To forward any ICSRs for data entry into the global drug safety database in timely manner
• · To inform QCer that review is done
• · To participate in sensitivity testing
• · To monitor mailbox
• · To populate and maintain Literature Weekly Tracker in timely manner
• · To populate ACTi Time accurately and in timely manner
• · To check if all urgent/immediate issues have been addressed in a timely manner
• · To report to senior team members and unit head, and provide them with regular updates regarding project status and metrics concerning enquiries
• · Assisting in departmental regulatory inspection preparedness for the company PV system and actively participating in PV inspections or audits

SPECIFIED ADDITIONAL RESPONSIBILITIES

• · To participate in Regulatory Agency Screening
• · Accessing and tracking EV MLM search and MLM ICSR results