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Job Overview:We are looking to hire a Drug Safety Assistant for our team! It can be for Remote basis within U.S.Responsible for assisting with the smooth running of the PV&DSS Department to ensure all adverse events are processed to the required standard and submitted to the client and the regulatory agencies (if required) within the agreed upon timelines. This post holder is responsible for providing this service to clients either as a support function to the client project groups or as standÂalone business.It is the responsibility of the post holder to provide all clients, both internal and external with the appropriate quality of service in a safe and cost —effective manner.He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company's Health & Safety Manual.Essential Job Duties:
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 (WD, 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.
Education/Qualifications:Required:
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 yrsSafety 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.
Degree 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.Experience:
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.
Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
