Senior Pharmacovigilance Scientist

Company Description

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer 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.

Our team in San Francisco is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

Job Description

About This Role:

HI-Bio, Inc., a Biogen company is seeking a Senior Pharmacovigilance Scientist. As a crucial member of the Safety team, the PV Scientist acts as a product lead, pivotal in managing Pharmacovigilance activities. This dynamic role involves overseeing the safety operations of clinical trials, spearheading safety signal management, and driving the development of aggregate reports and risk management plans. You will be the go-to expert, responding to safety inquiries from stakeholders, conducting literature reviews for safety insights, and ensuring compliance with global regulations. Reporting to the Head of Safety, you will collaborate with cross-functional teams to uphold and enhance our safety standards. Your contributions will not only support our commitment to patient safety but will also influence the strategic direction of our product lifecycle.

What You’ll Do:

• Lead and support the signal management process for assigned products, including signal detection and documentation.
• Synthesize safety data from various sources for comprehensive signal evaluation.
• Manage the strategy, review, and finalization of key safety aggregate reports.
• Liaise with cross functional teams to address safety queries effectively.
• Collaborate with Global Safety Officers on safety strategies for clinical trials.
• Oversee daily safety operations and develop safety management plans for trials.
• Ensure alignment of safety strategy and risk communications in investigational programs.

This position is Hybrid based out of our San Francisco office

Who You Are:

You are deeply invested in ensuring the utmost safety for patients involved in trials or using our treatments. With the ability to distill complex data into clear, actionable insights, you shine in a collaborative team setting. Your exceptional organization and time-management skills enable you to thrive in a fast-paced environment where your contributions make a significant impact on public health.

Qualifications

Required Skills:

• Minimum 7 years of Pharmacovigilance experience with a focus on aggregate reports and safety signal management.
• Bachelor's Degree in a biological or natural science, or health care discipline (advanced degree preferred).
• Proficiency in MedDRA terminology and its application.
• Strong computer skills, including advanced proficiency in MS Excel.
• Demonstrated analytical prowess and problem-solving capabilities.
• Capable of navigating a high-energy setting with numerous priorities.

Additional Information

The base compensation range for this role is $121,000 - $194,000. 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.

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.