• Sr Assoc Pharmacovigilance Operations

    US Tech Solutions (Thousand Oaks, CA)


    Job Details:

    Duration: 04 months contract

    Job Description:

    To support the safety surveillance process for products by performing follow up activities with patients and HCPs of individual case safety reports. Ensure vendor compliance with approved processes and training requirements. Oversee case quality of US ICSRs (CT and PM) including analysis and reporting of trends in quality measures. Point of accountability for managing one or more key vendor relationships for ICSR processing. Case processing point of contact for case related activities with assigned business partners. Case processing point of contact for audit related activities related to case processing. Accountable for measuring quality against contractual safety agreements. Accountable FDA point of contact for ICSR reporting. Submission of all individual safety reports to FDA, EMA and Business Partners.

     

    **Key Activities** - Perform case review. Support the development and delivery of convention-related training material. Ensure compliance of reporting activities with timelines and criteria. Interface with local office staff, CROs and business partners for case processing issues as necessary. Provide E2B submission support (nullification, redistribution). Address case-related queries from Business Partners. Support antibody re-testing coordination (non-LAO tasks for repeat testing).

    **Knowledge and Skills -** Understanding of global regulatory requirements for pharmacovigilance. Familiarity with clinical development processes . Case processing experience. Attention to detail. Competence in Argus safety systems and medical coding. Comprehensive English writing skills. Excellent phone conversations skills. Comprehensive knowledge on MS Office applications.

    **Key Relationships** **_-_** Case Management vendors, GQM/BPO, SOPS, MSRT, LSOs, Business Partners.

    Basic Qualifications:

    + Master’s degree OR

    + Bachelor’s degree and 2 years of experience OR

    + Associate’s degree and 6 years of experience OR

    + High school diploma / GED and 8 years of experience

    Top 3 must have skills:

    + Strong communication skills

    + Prior pharmacovigilance experience or exposure

    + Well organized

    About US Tech Solutions:

    US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

     

    "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"