- Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.
- Assist in producing queries of safety data for clients as appropriate.
- Assist in the generation and maintenance of the PV&DSS metrics.
- Assist Data Management or clients on reconciliation of safety databases.
- Provide input for monthly status reports.
- Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.
- Build and maintain good PV&DSS relationships across functional units.
- Demonstrate role-specific Core Competencies on a consistent basis.
- Demonstrate company Values on a consistent basis.
- Assist in the preparation of client meetings and liaise with clients where appropriate.
- Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
- Any other duties as assigned by management.
- Non-degree + 3-4 yrs relevant experience (or 1 yr safety experience)
- Associates Degree + 2-3 yrs relevant experience (or 1 yr safety experience)
- Associate degree RN + 1-2 yrs relevant experience
- BS/BA + 0 yrs
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Good communication.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Good keyboard skills with knowledge of MS Office and Windows application would be beneficial.
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