Basic purpose of the job*
Provide advanced data entry and contract management assistance to the Global Pharmacovigilance Agreement Database Coordinator, Global Pharmacovigilance Team, and/ or company departments involved with Pharmacovigilance agreements globally,including administrative and/or compliance matters.
Responsible for the review and accurate data entry of key information into the PV Agreement Database (PAD) and manage data for accuracy and completeness related to legal agreement(s) which contain Pharmacovigilance obligations as part of a complex project.
Assists the Global PV Pharmacovigilance Agreement Database Coordinator (GPV PADC) with pharmacovigilance agreement coordination for all external party agreements to ensure that the company is in compliance with all PV relevant industry standards and regulations globally.
Accountabilities:
Responsible for the review and data entry of legal agreements into the PV Agreement Database (PAD) and manage data for accuracy and completeness related to legal agreement(s) .
Assist with the monitoring and management of the PV Agreement service email box, including the review, drafting and responding to emails as instructed by GPV PADC, and documenting all required information as needed into the PV Agreement database.
Promptly notifies Supervisor when compliance issues are identified and assist as needed with handling and resolution.
Skills:
Experience working in a GMP/compliance environment subject to authority inspections (FDA, USDA, EMA etc...)is preferred.
Must have demonstrated ability to remain calm under pressure and work to meet strict regulatory and customer driven timelines
Performs in a rapidly changing regulatory environment with inter-departmental, global and external interfaces.
Requires a high level of problem solving skills including prioritization, innovation and creativity, managing information from multiple sources both internal and external.
.Education :
Minimum Education/Degree Requirements* Bachelor's Degree, or Associate's Degree at an accredited institution with a minimum of Two(2) years relevant experience that is directly related to the duties and responsibilities Preferred for this role.
Required Capabilities (Skills, Experience, Competencies)*
Must have Extensive Knowledge and with Microsoft Products (Teams, Outlook, Word, Excel, SharePoint, Access,etc.)and comfort with a paperless process.
Must have Superior Level of attention to detail, data entry accuracy, auditing skills, follow up,quality focused and strong data analysis, technical and problem solving skills.
Follow detailed instructions to organize, and process high volume, error free data on a consistent basis
Must Be Fluent in spoken and written English.
Knowledge of Animal Health Regulatory/Pharmacovigilance laws and guidelines preferred.
Experience with data entry in databases and/or visual analytics systems (i.e. MS,Access,SQL)
Exceptional oral and written communication skills are required.
Ability to work independently, follow detailed written processes with consistency and accuracy, under pressure, demonstrating initiative, emotional self-control and flexibility.
Exceptional organizational and time management skills required and have a demonstrated ability to remain calm under pressure and work to meet strict customer driven timelines.
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