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Associate, CSPV

Basking Ridge, NJ 07920

Posted: 06/03/2024 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 607732 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 30-32.14/hr **salary will be commensurate with experience 

Job Description:

This position is responsible for carrying out case receipt and data entry of post-marketing and clinical SAEs, and for tracking and reconciling SAE exchange. This position may assist in the monthly maintenance and reconciliation. This position also carries out some administrative tasks (e.g., mailbox management). This level interacts with internal and interdepartmental teams the majority of the time with occasional communication with external vendors and the global CSPV team This position is expected to handle ICSR issues in accordance with SOPs, SOIs, and experience and escalate more complex problems to management.

Case Receipt/Book-In/ Case Processing: Primarily responsible for case receipt/book-in processes. This includes monitoring of e- mail boxes for new cases, performing duplicate checks, booking cases into the safety database, entering PQC information/follow up outreach attempts and attaching electronic source documents, as well as creating/retrieving case file folders.

Reconciliation: Performs monthly maintenance and reconciliation of trackers for safety data exchanged with license partners and CROs. Participates in clinical SAE reconciliation

Querying/Reporting: Performs standard database searches/output in support of clinical-safety database reconciliation, as well for routine recurring monthly requests safety data.

Case Processing Policies and Procedures: Participates in development of process guides which are used to ensure consistency and compliance in case processing and adherence to regulatory guidelines.

Skills:
  • 1+ years of relevant PV experience and knowledge of FDA regulations

Education:
  • Bachelor's degree in Nursing, Pharmacy, or Healthcare related field 
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About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

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