- Kelly Services (Plainsboro, NJ)
- ** Pharmacovigilance QC Reviewer Team Lead IV** Location: Plainsboro NJ Shift: Hybrid role at least 3 days/week onsite is expected Duration: 1 year Pay ... submission of Individual Case Safety Reports (ICSRs) * Extensive quality control of ICSRs to ensure compliance...Experience Level: Total of 8+ years -- 5+ Years pharmacovigilance Team Lead/Management and 3+ pharmaceutical experience,… more
- Sumitomo Pharma (Trenton, NJ)
- …relevant to pharmacovigilance including but not limited to documentation of quality review findings, root cause analysis, trend analysis, implementation of ... (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will...case quality checks and supports the IM team with ad-hoc projects such as QC … more
- United Therapeutics (Trenton, NJ)
- …databases, preferably Argus + End-to-end case processing, including data entry, QC , medical review , and regulatory submissions **Preferred Qualifications** + ... about PV and enjoy being part of a collaborative team . The Associate Global PV Case Management Director plays...collection, management and reporting for postmarketing ICSRs for efficiency, quality , and compliance impacts. This role is critical in… more
- Ascendis Pharma (Princeton, NJ)
- …to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. + Performs Quality Control reviews of assigned cases to ensure the accuracy, ... + Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data … more