PSPM Support Associate (Fortrea)

Roles and Responsibilities

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 Include:

• Office Environment or remote.