Senior Manager, Clinical Safety Operations

  • Regular/Permanent
  • USA
  • Remote Options

Welcome to Orano

Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.

Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.

Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.

Job description

General Summary:

The Senior Manager of Safety Operations will oversee and manage the safety reporting operations in support of Orano Med clinical trials. This role ensures the accurate and timely collection, analysis, and reporting of safety data, in compliance with regulatory requirements and company policies. The ideal candidate will possess strong leadership skills, extensive knowledge of pharmacovigilance processes, and a deep understanding of clinical trial safety operations.

Job Duties and Responsibilities: 

  • Manage outsourced safety vendor(s) and processes to ensure compliance with contractual agreements and regulatory requirements.
  • 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 track key performance indicators (KPIs) for the central safety vendor and clinical resource organizations (CROs) managing individual studies.
  • Develop and maintain standard operating procedures (SOPs) and work instructions for oversight of outsourced safety operations.
  • Put in place study level safety processes and safety reporting mechanisms (e.g. write safety management plans, oversee safety gateway set up and maintenance).
  • Manage writing of safety reports, including periodic safety update reports (PSURs), Development Safety Update Reports (DSURs).
  • Liaise with regulatory authorities regarding safety reporting and provide responses to safety-related inquiries.
  • 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.

Our Full-Time Benefits

  • Competitive compensation 
  • Health, Dental, and Vision insurance – with generous employer contributions 
  • 401(k) with employer matching and contribution amounts 
  • Life insurance and Short- and Long-Term Disability insurance provided by the company
  • Generous Paid Time Off and holiday schedules 
  • Numerous Training and Development opportunities 
  • and more…   

Ideal qualifications

All candidates must meet the following minimum requirements in order to be considered for this opportunity.

Minimum Qualifications:

  • Advanced degree in a life science, healthcare, or related field (e.g., PharmD, MD, PhD) is preferred.
  • Minimum of 7-10 years of experience in pharmacovigilance or clinical trial safety operations, with at least 3-5 years in a leadership or managerial role.
  • Experience with global regulatory requirements and guidelines for clinical trial safety reporting (e.g., FDA, EMA, ICH).
  • Proven track record of successfully managing outsourced safety reporting operations for clinical trials in a pharmaceutical or biotechnology company.

Differentiating Qualifications:

  • Experience in oncology.
  • Experience in a start-up environment.

Skills and Knowledge Required: 

  • In-depth knowledge of pharmacovigilance principles, practices, and regulatory requirements.
  • Proficiency in safety database systems and safety data management tools.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
  • Strong analytical and problem-solving skills, with attention to detail and a commitment to data integrity.
  • Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously. 
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law. 

Senior Manager, Clinical Safety Operations

Ref: 2024-17476

Regular/Permanent

USA

Orano Med

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Find out more about Orano Med
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