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    PV Clinical Scientist - South San Francisco, United States - Planet Pharma

    Planet Pharma
    Planet Pharma South San Francisco, United States

    1 week ago

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    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 - 7 years of clinical / Pharmacovigilance experience or - 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
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