customer support
Posted 4 days agoPSPM Support Associate
at Fortrea
Bangalore, IndiaRemote
Responsibilities
- 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.
- 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.
- Support the Global Safety lead in the preparation of safety documentation for internal, client or regulatory audits.
- 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.
- 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.
Requirements
- Maintains a comprehensive understanding of Covance PSS Standard operating Procedure (SOPs) and other relevant controlled documents.
- Qualifications (Minimum Required): Non-degree + 1 year of Safety
- experience or 3 years relevant experience. Associate degree + 1 year of Safety
- 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.