Director - Pharmacovigilance Scientist
September 27
Description
• Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. • We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. • Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications. • We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. • With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. • The Pharmacovigilance Scientist (PVS) participates in the development and planning of safety strategies for assigned products in the clinical development and post-marketing. This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. The PVS will play essential role in developing PV/Safety documents in collaboration with other PV team members, and including cross-functional teams e.g., medical, clinical operations, regulatory affairs, Clin Pharm, and translational sciences.
Requirements
• MS, PhD, or PharmD • Previous safety or relevant experience in the pharmaceutical/biotech industry or health authority required, typically with at least 5 years of experience in PV/drug safety and risk management (preferably clinical development) • Passion, dedication, and a can-do attitude to the career of PVS • Good written and verbal communication skills • Ability to utilize safety system database (Argus) for purposes of medical case review and simple queries • Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS • Knowledge and experience in medical oncology and/or immunology is preferred • Ability to effectively present to cross-functional teams is required. • Have led the authoring/preparation of aggregate safety reports (DSURs) for products to meet regulatory requirements
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