Drug Safety Specialist - C3i Solutions

Employment Type

: Full-Time


: Miscellaneous

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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.

Summary: Conducts adverse event case quality management to include interfacing with clients to review weekly case flows, establish revisions and make judgments about case status. Will perform case processing to remain current with the activity. Also, includes case management for Global Quality Complaints in the Business Partner mailbox and acts as liaison for timely case completion.

Essential Duties and Responsibilities include the following:

Global Quality Complaint Management member:

    • Act as Business Partner point of contact responsible for continuous monitoring of the Business Partner (BP) mailbox.
    • Responsible for reviewing and triaging each new complaint.
    • Responsible for entering and/or releasing of Business Partner quality complaints in global complaint databases.
    • Liaison between national/international Business Partner and investigative sites to facilitate a timely completion of investigation.
    • Responsible for tracking of investigation due dates and forwarding reports to Business Partner.

Global Adverse Event Quality Management member:

    • Act as Global Adverse Event Quality Management point of contact responsible for the monitoring of the adverse event mailbox and Adverse Event interface..
    • Responsible for entering/completing Adverst Events into complaint databases.
    • Responsible for identifying appropriate manufacturing investigative site.
    • Responsible for lot genealogy identification, per SAP, to be included in records
    • Responsible for identifying and forwarding Adverse Event issues to appropriate Client personnel.
    • Liaison between Client case processing areas and Global Quality areas.
    • Resolve issues and work with the Client team to consistently assess case quality and establish plans and actions for improvements.
    • Responsible for development, updating and maintaining procedural documents.
    • Perform responsibilities in accordance with the SOPs and Working Practices.
    • Perform other duties as required.

Supervisory Responsibilities

This position has no supervisory responsibilities.

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: Based upon Client specific business requirements, minimum of a Bachelor s degree (B.A.) from four year college or university; minimum of two to five years previous pharmacovigilance or drug safety experience. The ability to handle high case volume and complex cases is critical, along with safety system experience, case processing, ability to interface with global safety teams/other teams formed to assess the continuing safety profile for the compound or product. RN experience preferred.

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, to write routine correspondence, to speak effectively and informatively, and respond to questions from customers, clients or associates of an organization, over the 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; 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.

Certificates, Licenses, Registrations: This position requires completion and certification of all program-related training.

C3iSolutions is an Equal Opportunity Employer M/F/D/V

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