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Pharmacovigilance Systems Program Manager

At C3i Solutions, we are committed to providing an incredible experience €” that starts with you. When you join our team, you become part of a network across the world delivering solutions for the most trusted healthcare brands, every day.  As our company grows, we're looking for you to grow with us. We want people who bring their own personality, strengths and talents to create something exceptional. People who will gain more experience than they could have ever imagined when they walked through the door. People who are ready to experience the world like never before. If you're ready to experience opportunity, join us.


Assist in the management of key initiatives within PV management


Program Manager for the Hosted Only Programs


Plan, attend and participate in client meetings


In conjunction with PV Management, define, track and execute implementation timelines and strategies


Track action items from client team and PV Staff meetings. 


Oversight of the PV Systems Service Desk


Oversight of resource allocation for scheduled program activities


Participate in SOP review as appropriate


Participate in the Non Conformance process


Assist in SOW, invoicing process


Point of contact for incident reports and outages


Responsible for the PV Notifications process


Assist in Oracle License maintenance


Support PV team with client audit preparation


Coordinate updates to the CBD for PV Systems Clients


Provide status reports for PV Systems Clients


Organize and ensure periodic review of PV Systems


Responsible for the quality control (QC) of the documentation of the completed change control


Ensure all documentation is filed as appropriate


Responsible for the QC of the documentation of the validation packet


Organization of associated documentation


Ensure all documentation is filed as appropriate


Oversight for onboarding and transition of personnel


Maintain PV client contact information and client code list


Maintain current PV contract list and expiration list


 


Job Specifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


 


Education and/or Experience: Bachelor's Degree with strong communication and organizational skills; Computer literate with working knowledge of Microsoft Office software.  Functional Skills can be provided through experiences at either of bio-pharmaceutical organizations or through service providers such as CROs.


 


Language Skills: Excellent oral communication skills and writing skills. Ability to read and interpret documents such as safety rules, standard operating procedures (SOPs) or other job aids; Write routine correspondence, speak effectively and informatively, and respond to questions from customers, clients or associates by phone or in-person.


 


Reasoning Ability: Excellent analytical ability and problem solving skills, including ability to trouble shoot issues and propose solutions; Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form, and to deal with problems involving several concrete variables in standardized situations.


 


Computer /Technical Skills: Strong MS Excel, Word, Visio, and PowerPoint skills; Computer literate; Previous safety database experience highly desirable.


 


Other Skills and Abilities:. This position may require participation in, and possible travel to, training sessions, completing self-study, certification and call monitoring; Ability to manage difficult, irate or emotional customers while maintaining composure; Ability to multi-task; Demonstrated ability to manage time, establish and maintain productive working relationships with all levels within the organization; Strong data integrity and attention to detail. Ability to work independently and handle multiple tasks in a fast-paced environment; Ability to meet and keep to very tight deadlines; Must be very detail orientated, organized and punctual: Ability to work with many people at one time.


 


C3iSolutions is an Equal Opportunity Employer




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