Senior Safety Physician

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.

• 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...

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.