PSPM Support Associate

Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible 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 and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of Responsibilities: Provide support for the set- up, maintenance and close out of Global or Regional projects in clinical trial and /or in post marketing studies, where delegated by the Global Safety lead of PSS Management team. Support the Global Safety lead in preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision. Support the Global Safety lead in preparation of study specific job aids, instructions, trainings and templates Support systems set up during study start up and ongoing maintenance. Support the Global Safety lead with project specific functional management for assigned projects (access requests, training assignment etc.) Support Global Safety lead with reconciliation of safety databases, if appropriate. Support Global Safety Lead in drafting/modifying and delivering safety presentations as required, to external and internal stakeholders. Support the Global Safety lead in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided. Assist in TMF management activities as required. Support the Global Safety lead in the preparation of safety documentation for internal, client or regulatory audits. Maintains a comprehensive understanding of Covance PSS Standard operating Procedure (SOPs) and other relevant controlled documents. Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client. Demonstrate role-specific competencies on a consistent basis. Demonstrate company values on a consistent basis. Qualifications (Minimum Required): Non-degree + 1 year of Safety experience or 3 years relevant experience. Associate degree + 1 year of Safety experience or 2 years relevant experience. BS/BA + 1 year of relevant experience. MS/MA + 1 year of relevant experience. PharmD + 1 year of relevant experience. For PharmD, a one-year residency of fellowship can be considered as relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. Experience (Minimum Required): High degree of accuracy with attention to detail. Functions as a team player and offer peer support as needed. 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 ¨ Mentoring skills preferred.

Preferred Qualifications

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