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Lead Pharmacovigilance Scientist
2 months ago
About This Role
HI-Bio, Inc., a Biogen company, is in search of a Senior Pharmacovigilance Scientist. In this essential role within the Safety team, the Pharmacovigilance Scientist serves as a product lead, instrumental in overseeing Pharmacovigilance operations. This multifaceted position entails managing the safety aspects of clinical trials, leading safety signal management initiatives, and driving the creation of comprehensive aggregate reports and risk management strategies. You will be the primary resource for safety inquiries from various stakeholders, performing literature reviews to gather safety insights, and ensuring adherence to global regulatory standards. Reporting directly to the Head of Safety, you will work collaboratively with cross-functional teams to maintain and enhance our safety protocols. Your efforts will not only support our dedication to patient safety but will also shape the strategic trajectory of our product lifecycle.
Key Responsibilities:
- Direct and facilitate the signal management process for designated products, encompassing signal detection and documentation.
- Integrate safety data from diverse sources for thorough signal evaluation.
- Oversee the strategy, review, and finalization of crucial safety aggregate reports.
- Collaborate with cross-functional teams to effectively address safety inquiries.
- Partner with Global Safety Officers on safety strategies for clinical studies.
- Manage daily safety operations and formulate safety management plans for trials.
- Ensure alignment of safety strategies and risk communications in investigational programs.
This position offers a hybrid work arrangement.
Who You Are:
You are deeply committed to ensuring the highest level of safety for patients participating in trials or utilizing our therapies. With a talent for distilling complex data into clear, actionable insights, you excel in a collaborative team environment. Your outstanding organizational and time-management skills empower you to thrive in a fast-paced setting where your contributions significantly impact public health.
Qualifications
Required Skills:
- At least 7 years of experience in Pharmacovigilance, particularly in aggregate reporting and safety signal management.
- Bachelor's Degree in a biological or natural science, or health care discipline (advanced degree preferred).
- Proficient in MedDRA terminology and its application.
- Strong computer skills, including advanced proficiency in MS Excel.
- Proven analytical skills and problem-solving abilities.
- Capable of navigating a high-energy environment with multiple priorities.
Additional Information
The compensation range for this role is competitive and is determined by various factors including relevant experience, internal equity, and job location. This role is also eligible for participation in Biogen's long-term incentive grants and other incentive programs. Biogen provides a comprehensive benefits package that includes medical, dental, life, and disability insurances, vacation, end-of-year shutdown, and 401K participation with matching contributions.
Why Biogen?
We are a global organization committed to excellence and innovation. As a mid-sized biotechnology firm, we offer the stability and resources of an established company while fostering an environment where individual contributions are valued. Our team consists of talented and passionate professionals who have exceptional opportunities for learning, growth, and skill enhancement. Together, we strive to deliver life-changing therapies, with every role playing a crucial part in our mission. We are dedicated to building a culture of inclusion and belonging that reflects the communities we serve and the patients we support. We believe that diverse backgrounds, cultures, and perspectives strengthen our company and drive innovation.
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.
