Senior Medical Safety Officer

3 weeks ago


Plano, Texas, United States Orano Med, LLC. Full time
Job Summary:

Orano Med, LLC. is seeking a highly skilled Senior Medical Safety Officer to oversee the safety aspects of clinical trials and post-marketing surveillance. The ideal candidate will have a strong background in safety management, with a proven track record of preparing and submitting safety reports to regulatory authorities.

Key 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 and review safety reports, including DSURs, PSURs, and other regulatory submissions.
• Provide medical review for individual case safety reports.
• Work closely with cross-functional teams to ensure integrated safety management.

Requirements:

• 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.

Preferred Qualifications:

• Prior experience within a start-up environment preferred.

Skills and Knowledge:

• 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 Med, LLC. 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.

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