Senior Pharmacovigilance Safety Specialist

CRO -- Snr Pharmacovigilance ( PV ) Safety Specialist.

Role responsibilities:

• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
• entry of safety data onto adverse event database(s) and tracking systems
• review adverse events for completeness, accuracy & appropriateness for reporting
• write patient narratives
• code adverse events accurately using MedDRA
• determine expectedness/listedness against appropriate label
• perform case medical review & reports to worldwide regulatory agencies
• prepare follow-up correspondence consulting the medical staff.
• ensure all cases that require
• reporting of endpoints to relevant personnel within study timelines
• provide independent QC of AE reports for other members of the group
• May execute routine quality review of AE reports and aggregate reports
• Participate in signal detection, trend and pattern recognition activities
• Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and reports.
• Work with Data Management or client on reconciliation of safety databases,
• Monitor workflow for assigned studies/programs to all deadlines
• Draft/modify and deliver safety presentations
  • Serious Adverse Event reporting at Investigator meetings
  • Client capabilities meetings, as appropriate
  • "Department Overview" to internal clients
• Maintains a comprehensive understanding of SOPs, Work Instructions (WI), guidance documents and safety management directive & PV reporting.
• Knowledge of other procedural documents, e.g. SOPs, etc. that impact PSS.
• Assist in the development of departmental WI and SOPs.
• Compliant safety reporting to US and international reporting regulations,
• Support/train safety staff in case-handling, adverse event reporting etc
• Prepare Safety Management Plans (SMPs), Reconciliation Plans
• Decision-making adverse event reporting within guidelines of projects
• Assist PSS management to identify out of scope work.
• Participate in project team and client meetings and liaise with clients
• Prepare and/or participate in client or regulatory audits.
• Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
• Assist in set-up of, and the provision of data to Safety Committees/DSMBs.
• Assist in the co-ordination of endpoint committees, as required