What are the responsibilities and job description for the Associate, CSPV position at HireTalent?
Job Title : Associate, CSPV
Job Schedule : Prefer a hybrid-based candidate in the event travel to the Basking Ridge office is required. Candidate can be fully remote based (however must be currently located in NY / NJ / PA area).
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 (, 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.
Years of Experience
Experience Details
Required / Preferred
or More Years
relevant experience
preferred
or More Years
PV experience
preferred
knowledge of FDA regulations.
preferred
