- 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 yrsDegree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
- *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
- 2 to 5 years of experience required, safety experience preferred.
- Supervisory experience, but not necessarily line management experience.
- Office experience or equivalent training.
- Ability to set priorities and handle multiple tasks.
- Pays attention to detail.
- Good team player.
- Good written and verbal communication skills.
- Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Ability to operate standard office equipment.
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