Job Description

Associate, Global Patient Safety Operations

Initial 6mth contract (potential extension / conversion)

Hybrid - preference 3days onsite each week

The Opportunity:

• Assist with the oversight of the Pharmacovigilance (PV) CRO performing case management and study support activities.
• Assist with the management of the PV CRO to ensure compliance within the required timelines.
• Provide vendors with relevant clinical study documents and updates.
• Coordinate the review and filing of study plans and associated documents.
• Coordinate the review and filing of PV CRO documents and monthly compliance reports.
• Track and maintain well-organized department files, including listings and trackers received from CROs.
• Support eTMF oversight of safety case files and relevant documents with PV and clinical CROs.
• Participate and review TMF plans to capture PV and clinical CRO’s filing responsibilities.
• Maintain PV CRO distribution contact lists and oversee Clinical CRO site contact lists.
• Maintain meeting materials, schedule meetings, develop agendas, and track meeting minutes.
• Assist with MedDRA and WHODrug coding impact analysis review.
• Prepare aggregate periodic reports for departmental review and CRO distribution.
• Assist with Standard Operating Procedure (SOP) cross-functional review in Quality Management System.
• Perform administrative tasks to support GPS team, as needed.
• Support GPS Operations team in other PV activities as appropriate to experience and expertise.

Required Skills, Experience and Education:

• Bachelors Degree OR Associates with min. of 1 year of relevant industry experience in lieu.
• Experience in clinical trial conduct and safety reporting.
• Good understanding of Software: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat, eTMF software, quality management systems (i.e., Veeva Systems).

Preferred Skills:

• Experience working with CROs/vendors and management of external resources is preferred.
• Opportunities for successful candidates will be available to learn about safety reporting in global clinical trials and other aspects of drug safety.

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