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.
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
Position Summary:
This position will be responsible for overseeing the safety aspects of Orano Med clinical trials, ensuring patient safety, medical review of individual case safety reports, signal detection and contributing to authoring period reports and safety sections of relevant clinical documents.
Job Duties and Responsibilities:
- Oversee and manage the safety aspects of clinical trials and post-marketing surveillance.
- Ensure all safety activities comply with regulatory requirements and industry standards.
- Monitor and analyze safety data to detect safety signals and trends and take appropriate action.
- Prepare / review safety reports, including DSURs, PSURs, and other regulatory submissions. Provide medical review for individual case safety reports.
- Work closely with cross-functional teams, including clinical development, regulatory affairs, and pharmacovigilance, to ensure integrated safety management.
- Prepare consent form risk language, provide safety input into relevant clinical and regulatory documents (protocols, investigator brochures etc.
- Liaise with regulatory authorities, external safety committees, and other stakeholders regarding safety issues and updates.
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:
- MD or equivalent medical degree required.
- Minimum of 8-10 years of experience in safety management.
- Prior experience within oncology and radioligand therapies required.
- Extensive experience with clinical trial safety and post-marketing surveillance.
- Proven track record of preparing and submitting safety reports to regulatory authorities.
Differentiating Qualifications:
- Prior experience within a start-up environment preferred.
Skills and Knowledge Required:
- Familiarity with radioligand therapies and their safety profiles is highly preferred.
- Strong understanding of regulatory requirements and guidelines related to drug safety.
- Excellent analytical skills with the ability to interpret complex safety data and identify potential risks.
- Strong written and verbal communication skills, with the ability to effectively convey safety information to various stakeholders.
- Proven problem-solving abilities with a proactive and strategic approach to safety management.
- Ability to work collaboratively in a fast-paced, startup environment, with a strong team orientation.
- Meticulous attention to detail in all aspects of safety management and reporting.
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.
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
Find out more about Orano Med
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