- Aequor (Thousand Oaks, CA)
- …case management and medical review SOPs and regulatory requirements for Pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class ... Proficiency in technical safety systems including the Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development Knowledge of products and… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance ... Grifols pharmaceutical products. + Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with… more
- Bristol Myers Squibb (San Diego, CA)
- …aims to be the global leader in radiopharmaceuticals. The Director of Pharmacovigilance Safety Operations will be responsible for overseeing and managing the ... pharmacovigilance activities to ensure the safety of our products...safety database + Regulatory Compliance: Ensure compliance with global pharmacovigilance regulations and guidelines, including timely submission of safety… more
- Bristol Myers Squibb (San Diego, CA)
- …the global leader in radiopharmaceuticals . The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of product ... and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards,… more
- United Therapeutics (CA)
- …compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety quality, ... biology, or BSN, and 8+ years of experience in pharmacovigilance in either case processing or quality assurance of...chemistry or biology, and 6+ years of experience in pharmacovigilance in either case processing or quality assurance of… more
- Sumitomo Pharma (Sacramento, CA)
- …+ Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a ... Experience in oncology is highly desired + **Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and… more
- US Tech Solutions (CA)
- …* Perform **quality review** of **external providers'** reconciliation tasks for clinical and post-marketing ( **medical information, product complaints, and ... This role will be 100 % remote. Candidates must posses **3 to 5 years of experience** or application/environment specific knowledge to perform tasks where large quantities of information, data or documents need to be maintained or manipulated in a **structured… more
- Sumitomo Pharma (Sacramento, CA)
- …Strategic Alliance (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will be responsible for ... with Quality on corrective action and preventative actions relevant to pharmacovigilance including but not limited to documentation of quality review findings,… more
- Ascendis Pharma (Palo Alto, CA)
- …Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for managerial oversight ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… more
- United Therapeutics (Sacramento, CA)
- …role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, ... or related field + 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a...bachelor's degree or + 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a… more
