Tecnologia a serviço da vida
Operations Coordinator
Location
Brazil
Posted
77 days ago
Salary
0
Seniority
Senior
Job Description
Operations Coordinator
Integra Saude Digital
• Team coordination: Full management of the implementation team. • Relations with municipalities: Direct contact with local government managers. • Planning: Establishing schedules and priorities. • Logistics: Organizing routes and travel. • Travel costs: Estimating and controlling expenses. • Reports: Documenting completed trips. • Infrastructure: Vehicles and accommodation for teams. • Monitoring: Tracking system usage. • Inspection oversight: Supporting inspection strategies. • Procurement and supervision: Purchasing and regional management.
Job Requirements
- Bachelor's degree in Business Administration, Production Engineering, or related fields.
- Postgraduate degree in related fields (preferred).
- Minimum of 3 to 5 years of experience in implementation roles and people management.
- Proficiency in Microsoft Office tools.
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Director, Pharmacovigilance Operations
CelcuityCelcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. Celcuity is an Equal-Opportunity Employer.
• Oversee end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases. • Ensure global compliance with pharmacovigilance regulations, including timely ICSR submission, high-quality case processing, and support for aggregate reporting. • Provide oversight and support of the PV vendor activities, including but not limited to the establishment and monitoring key performance indicators (KPIs) and vendor audits. • Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations. • Collaborate with stakeholders to ensure alignment of PV strategy, compliance, and status of the PV system. • Support development and maintenance of internal PV policies, SOPs, training programs, and the maintenance of the pharmacovigilance system. • Support safety signal detection activities and participate in safety governance committees. • Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements. • Lead the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreements (SDEAs). • Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes. • Contribute to the preparation and submission of safety reports including but not limited to RMPs, DSURs, PSUR/PBRER, PADER, and PSMF. • Develop and author responses to PV-related health authority inquiries and other regulatory communications. • Other duties as assigned.


