Job Description

About This Role:
HI-Bio, Inc., a Biogen Company is seeking a Global Safety Officer to be a crucial member of our safety team, focusing on the medical safety aspects of our products. Your role will be instrumental in reviewing and analyzing safety data from various sources, including clinical studies and post-marketing settings. Tasked with overseeing signal assessments and ensuring the integrity of safety conclusions, you will provide strategic leadership within our clinical development programs. Moreover, you will manage safety surveillance and risk management strategies, ensuring our products' benefit-risk profiles are thoroughly assessed. Your expertise will further extend to regulatory filings and representing the safety team in key discussions, thereby directly contributing to the company's commitment to patient safety and regulatory compliance.

What You’ll Do:

• Serve as the safety officer for assigned products, providing oversight and analysis of safety data.
• Oversee signal assessments and derive safety and benefit-risk conclusions from aggregate reports.
• Lead the medical review and approval of individual case safety reports (ICSRs).
• Ensure compliance with adverse event reporting requirements for investigational and marketed products.
• Provide strategic safety leadership within clinical development teams.
• Respond adeptly to safety queries from health authorities.
• Contribute safety expertise to develop strategic frameworks for clinical development plans.
• Develop and execute risk management strategies to ensure product safety.
• Foster collaborative relationships with cross-functional program counterparts in various scientific and clinical domains.
• Account for the accurate assessment of Benefit/Risk in Aggregate Reports.

Who You Are:
You are a medical doctor with a passion for patient safety and a keen eye for detail. Your analytical skills and experience in pharmacovigilance enable you to lead safety strategies and risk management with confidence and clarity. You thrive in cross-functional team environments and are committed to advancing healthcare through vigilant safety oversight.

Qualifications

Required Skills:

• MD with a subspecialty focus in kidney disease preferred.
• A minimum of 5+ years in the pharmaceutical industry or clinical care setting, with 3-5+ years dedicated to pharmacovigilance.
• Experience with clinical trial safety, signal evaluation, and risk mitigation.
• Familiarity with pre- and post-marketing safety regulations in the US and EU.
• Strong written and verbal communication skills and the ability to work effectively in a team.
• Leadership capabilities with strong problem-solving, conflict resolution, and analytical skills.
• A proven track record of accountability and delivering results.

The base compensation range for this role is $186,000 - $309,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

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Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.