About this role
About This Role:
As the Head of Drug Safety & Pharmacovigilance (PV) for the West Coast Hub, you will be at the forefront of ensuring the safety and efficacy of our therapies focused on immune-mediated diseases. This pivotal position requires strategic oversight and scientific leadership to maintain the integrity of our global safety surveillance activities. Your role is essential in safeguarding patient well-being and optimizing the benefit-risk profile of our therapies throughout their lifecycle. Reporting directly to the Head of Regulatory & PV, you will spearhead safety science, clinical and post-marketing surveillance, and regulatory safety engagement. You will collaborate closely with teams across Medical Safety, Clinical Development, and Regulatory Affairs to drive strategic decisions that expedite the delivery of impactful medicines.
What You’ll Do:
Define and implement the long-term pharmacovigilance strategy for the West Coast Hub portfolio.
Execute PV scientific and operational goals to enable rapid and compliant development of therapies.
Develop and oversee policies and processes for safety science, benefit-risk assessment, and signal detection.
Serve as a senior representative in global health authority interactions, including regulatory meetings and submissions.
Oversee medical evaluation of safety data for signal detection and interpretation across products.
Lead the development and execution of Risk Management Plans (RMPs) and REMS programs.
Drive innovative safety surveillance activities aligned with global regulatory requirements.
Build and mentor a high-performing team of PV professionals, fostering a culture of accountability and innovation.
Partner with cross-functional teams to influence product strategy and drive integrated execution.
Who You Are:
You are a strategic thinker with a deep passion for patient safety and drug efficacy. Your extensive experience in pharmacovigilance and drug safety equips you to lead with confidence and precision in a dynamic environment. You excel in fostering collaboration and innovation, guiding high-performing teams to achieve excellence. Your exceptional communication skills and executive presence enable you to influence decisions at all organizational levels, ensuring that safety remains a top priority.
Required Skills:
MD with post-graduate clinical training.
12+ years of progressive experience in pharmacovigilance/drug safety in the biotech/pharma industry.
Demonstrated success in global safety surveillance and regulatory engagements.
Expert knowledge of global PV regulations, FDA/EMA requirements, and clinical safety reporting.
Strong analytical and scientific reasoning skills.
Outstanding communication and executive presence.
Proficiency with safety databases and analytics platforms.
Domestic and international travel may be required.
Preferred Skills:
Advanced training in pharmacoepidemiology or MPH.
Experience supporting immune-mediated or rare diseases.
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Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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.
Other facts
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities.
We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html
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What you'll do
- Define and implement the long-term pharmacovigilance strategy for the West Coast Hub portfolio while overseeing safety science and regulatory safety engagement. Collaborate with cross-functional teams to drive strategic decisions that expedite the delivery of impactful medicines.
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