we are a pharmaceutical company developing innovative therapies for rare diseases with significant unmet needs. We leverage our proprietary plant cell-based protein expression platform, along with other modalities including small molecules and antibodies. we have successfully commercialized two recombinant protein-based products, is advancing a gout program currently in Phase 2 development, and continues to build a pipeline focused on renal diseases while exploring novel technologies and early-stage opportunities. If you are looking to join a dynamic, professional team that supports personal and career growth, we would be happy to hear from you.
Requirements:
Manage the companys safety surveillance activities for products under clinical development, including case processing, periodic safety data assessments, signal detection, literature reviews, preparation and coordination of internal safety committees, and maintenance of an overall safety surveillance plan. Develop, maintain, and deliver training on internal PV SOPs and safety procedures, ensuring alignment with evolving regulatory requirements. Review/contribute to safety content for clinical and regulatory documents, including IBs, protocols, ICFs, CSRs, and DSURs. Execute and manage Safety data Exchange Agreements (SDEA) with partners for post-marketing products. Support and manage clinical trial operations activities throughout the clinical study lifecycle.
Manage the companys safety surveillance activities for products under clinical development, including case processing, periodic safety data assessments, signal detection, literature reviews, preparation and coordination of internal safety committees, and maintenance of an overall safety surveillance plan. Develop, maintain, and deliver training on internal PV SOPs and safety procedures, ensuring alignment with evolving regulatory requirements. Review/contribute to safety content for clinical and regulatory documents, including IBs, protocols, ICFs, CSRs, and DSURs. Execute and manage Safety data Exchange Agreements (SDEA) with partners for post-marketing products. Support and manage clinical trial operations activities throughout the clinical study lifecycle.
This position is open to all candidates.
