Duration:
6 Months + (30/hrs +/- per week)
Job Description:
Our client is in need of a PV Operations consultant who will be responsible the collection, review, and processing of adverse event (AE) information received by CROs and/or Investigator Initiated Studies, Corporate partners and any other source in compliance with applicable FDA and global regulations, Standard Operating Procedures (SOPs), and guidelines. This PV professional will be conducting and/or reviewing/approving of periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies. The CRO is doing most of the heavy lifting so this professional will just have to ensure timelines are followed and handing all metric based reporting. Not only compliance but through reconciliation in EDC working with clinical to make sure things are good at the site. This person MUST be well versed with all PV regulations/guidance’s. On a monthly basis signal meetings occur, this PV Operations K will take the agenda for the meeting, do the minutes for the meeting, and write report. Get the 3 stakeholders to provide input ad get the report signed in an appropriate turn around time. The Client also needs someone who is competent, hands on and preferably has worked in small to midsized companies.
Skills:
Pharmacovigilance (PV) Operations
Serious Adverse Events (SAE)
SUSARs
Global Experience
Oncology
Education:
BS
Average Day:
Everybody is east coast central time. The PV Consultant will monitor SAE’s check source form, look at what CRO is documenting, do QC there to verify CRO data as manual process. Ensure the medical monitors on on track and make sure 7 day 15 day and periodic reports are being reviewed according to safety management plan. Work with global safety DB vendor to make sure report is uploaded into DB and sent back to QC and review. Monthly basis signally agenda meeting minutes report. Get 3 ppl to give input and get report signed in decent turn around time.
Remote: PV Operations Consultant (233840)
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