Associate, Global Patient Safety Operations Job at Planet Group, Saginaw, MI

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  • Planet Group
  • Saginaw, MI

Job Description


Associate, Global Patient Safety Operations 

The Opportunity:

  • Assist with the oversight of the Pharmacovigilance Contract Research Organization (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:

  • Bachelor’s degree in natural or health sciences or a minimum of 1 year of relevant industry experience in lieu.

  • Knowledge of Good Clinical Practice (GCP) Guidelines.

  • 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.

  • Reliable, self-motivated, focused, positive attitude, proactive and solution-oriented problem solver, able to adapt to changes in priorities and tasks.

  • Attention to detail and excellent written and verbal communication skills.

  • Demonstrate the ability to manage time, prioritize tasks, and organize information effectively to meet timelines.

  • Excellent interpersonal skills include ability to work in cross-functional team environments and with external vendors.

  • Able to create and sustain strong working relationships with remote staff use video conference and instant message, as needed.

  • Exercise discretion regarding highly confidential internal and external communications.

Job Tags

Contract work,

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