Senior Manager, Clinical Safety Operations

Orano Med Theranostics

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

Orano Med LLC has opening for Senior Manager, Clinical Safety Operations in Plano, TX.

Key Responsibilities

• Oversee and manage the safety reporting operations in support of Orano Med clinical trials.
• Ensure the accurate and timely collection, analysis, and reporting of safety data, in compliance with regulatory requirements and company policies.
• Manage outsourced safety vendor(s) and processes to ensure compliance with contractual agreements and regulatory requirements.
• Develop and track key performance indicators (KPIs) for the central safety vendor and clinical resource organizations (CROs) managing individual studies.
• Ensure compliance with all relevant regulatory guidelines and requirements (e.g., FDA, EMA, ICH) related to clinical trial safety reporting including the accurate and timely entry of safety data into safety databases.
• Develop and maintain standard operating procedures (SOPs) and work instructions for oversight of outsourced safety operations.
• Put in place and maintain the study level safety processes and safety reporting mechanisms (e.g. write safety management plans, oversee safety gateway set up and maintenance).
• Manage writing safety reports, including periodic safety update reports (PSURs), Development Safety Update Reports (DSURs).
• Manage and oversee the signal detection and literature search/review.
• Liaise with regulatory authorities regarding safety reporting and provide responses to safety-related inquiries.
• Perform quality review of ICSRs/SUSARs and aggregate reports. Lead initiatives to implement new technologies and tools to support safety data management and reporting.
• Stay current with industry trends, regulatory updates, and best practices in pharmacovigilance and safety operations.
• Support in drafting/reviewing the Master Service Level (MSA) and SDEA/PVA agreements. Oversee PV budget, negotiate the pricing, perform budget forecasting and variance analysis.
• Maintain the PV system to be always audit/inspection ready and lead/act as the point of contact for the audit/inspections.
• Position requires 15% domestic and international travel.
  

All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.

Minimum Qualifications

3 years of experience in a leadership or managerial role with respect to clinical safety operations and compliance; Employer will accept a Bachelor's degree in Pharmaceutical Sciences, or related field, and 10 years of experience in the job offered or in a clinical safety compliance-related occupation.

• Expertise with global regulatory requirements and guidelines for clinical safety reporting in phase I, II and III (e.g., FDA, EMA, MHRA, etc.);
• Successfully managing outsourced safety reporting operations and compliance in or for a pharmaceutical or biotechnology company;
• Experience working in Oncology Therapeutic Area;
• Experience working in Start-up environment;
• Experience attending FDA/ EMA and other health authorities audits and inspections;
• Study start up to closure activities including setting up the clinical database (Rave/Inform), Safety database (Argus 8.4.3/ArisG/LSMV), and dictionaries like MedDRA & WHODD;
• Data migration and SDEA/PVA agreements (draft/review and maintenance)