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Clinical Research Associate
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Clinical Research Associate
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Associate Director, Clinical Science
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PV Clinical Associate - South San Francisco, CA, United States - Planet Pharma
Description
PV Clinical Associate 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 Drug Safety.
The PV Clinical Associate leads clinical review of USDS cases (processed in-house or externally by the vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities.
All responsibilities are performed under the direction of the PV Clinical Manager- Associate.Key Accountabilities:
Completes drug 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 Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database.
Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessmentPerforms 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
Performs trend analysis of vendor case processing issues and escalates to vendor and USDS management
Responsible for developing executive summary on the quality trends observed on a quarterly basis
Responsible for training internal USDS 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 Associate/Vendor staff via the communication module
Accountable for training internal and external staff members on using communication module
Performs daily reconciliation of outgoing communications
Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)
Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
Supports PV Clinical Specialists 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 Drug Safety management
Responsible for the preparation and development of Drug 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
Demonstrates strong, dynamic leadership skills
Works well independent or within teams and is effective in collaborating with others internally and externally
Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems and effectively make decisions of moderate complexity and scope e.g., evaluate, interpret and present highly complex data
Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
Ability to flex and thrive in an agile and fast-changing environment
Strong attention-to-detail
Education, Experience, and Other Requirements:
Health Care Professional degree (Required)
Minimum 0-2 years of clinical experience (Required)
Writing experience; science/medical writing (Required)
Computer proficiency (Required)
Data entry experience (Preferred)
Able to travel as per business needs
Pay Rate Range:
$25-33/hr. Salary will be commensurate with experience
