Head of PV & Drug Safety, West Coast Hub
3 days ago• San Francisco, CA
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.
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- 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.
#LI-TD1
Job Level: Management
Additional Information
The base compensation range for this role is: $281,000.00-$387,000.00
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.
Client-provided location(s): San Francisco, CA
Job ID: Biogen-REQ22344
Employment Type: FULL_TIME
Posted: 2026-01-22T19:14:34
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)