Medical Director, Drug Safety Job at People With Chemistry, San Carlos, CA

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  • People With Chemistry
  • San Carlos, CA

Job Description

(Sr.) Medical Director, Drug Safety Remote Based Oncology-Hematology | Cell Therapy Pay Range: $280,000 - $340,000 Overview: Meet are exclusively partnering with a mid-sized biotech who have developed a T-cell based immunotherapy platform targeting both solid and liquid tumors. Off the back of their first FDA approval they are anticipating significant growth of 30% across multiple business sectors in H2 of this year. Reporting to the VP, Drug Safety you will Provides medical expertise within the Drug Safety department throughout the lifecycle of products in development and post marketing. Contributes to the analysis, review, and approval of Individual Case Safety Reports (ICSRs) and contributes to and provides the medical review for aggregate safety reports, including but not limited to analyses of adverse events, Periodic Reports or marketed and investigational products. Supports the ongoing evaluation of safety information for products in development and on the market for signal detection purposes and to provide proactive risk management strategies. Responsibilities: Reviews all appropriate safety data from various sources throughout the product development life cycle to proactively identify any new safety issues that may require further evaluation to determine a causal relationship with products in development or on the market. Conducts medical review and assessment of clinical trial and post marketing cases for all products, ensuring the case narratives are medically accurate, the events within cases are properly coded and have the proper labeling assessment, and that cases are queried for additional information as needed. Authors or provides medical review of all aggregate safety reports such as Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Investigational New Drug (IND) Annual reports, and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission. Authors or contributes to safety sections of regulatory submissions, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and responses to regulatory authorities Participates in investigators' meetings to provide training on adverse events reporting as required. Education and Background: Medical degree Knowledge of pre- and post-marketing US and Global regulations Familiar with Medical Coding To learn more about the position please contact sean@peoplewithchemistry.com , or contact 628-229-9023

Job Tags

Remote job,

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