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, Remote work,