PV Clinical Scientist - ICSR Case Management

Job Description

Summary Of Position

The PV Clinical Scientist - ICSR Case Management performs the tactical and operational job

responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Patient Safety (USPS). The PV Clinical Scientist - ICSR Case Management performs clinical review of USPS cases (processed in-house or externally by the vendor) and supports the US Patient Safety PV Clinical Manager - ICSR Case Management in all activities. All

responsibilities are performed under the direction of the PV Clinical Manager - ICSR Case Management.

Key Accountabilities

Completes patient safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and company Standard Operating Procedures(SOPs) Reviews, evaluates, and verifies potential AE information during triage to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via internal global safety database. Performs seriousness / validity/causality assessments and conducts quality review of all cases (as applicable) based on their medical assessment Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable) Responsible for Clinical Review of cases processed in-house and by vendors Understands case processing data to evaluate error rates and potential compliance impact Responsible for training internal USPS and/or vendors staff or team in collaboration with SP PV oversight based on trend analysis Responsible for ensuring appropriate data correction in the safety database for identified issues or errors Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Scientist - ICSR Case Management/Vendor staff via the communication module Accountable for training internal and external staff members on using communication module Performs daily reconciliation of outgoing communications Supports PV Clinical Scientist - Product in tasks and projects as needed Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed) Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable) Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Patient Safety management Responsible for the preparation and development of Patient Safety presentations and participates in the

education offer internal /external stakeholders as applicable Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database per internal SOPs Provide support during audits and inspections Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified For Success

Demonstrates capability to comprehend medical information Demonstrates ownership, initiative and accountability Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility Ability to follow direction / guidance from USPS leadership or colleagues as required Works well independent or within teams and is effective in collaborating with others internally and externally Communication and presentation

skills; highly effective at summarizing and presenting key considerations and decision-points Strong attention-to-detail Able to travel local / international as per business needs

Education,

Experience, And Other

Requirements

Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD) (Required) Minimum 5 - 7 years of clinical / Pharmacovigilance

experience or 3 - 5 years with Masters or 0-2 years with PhD (Required) Writing

experience; science/medical writing (Required) Computer proficiency (Required) Data entry

experience (Preferred) Project Management (Preferred)

Pay Rate Range: $40-55/hr.

Salary Will Be Commensurate With

experience

The Planet Group Of Companies Is An

equal opportunity employer. We celebrate

diversity and are committed to creating an inclusive environment for all employees.