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.
Requirements
Required Skills:
MD/PhD 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: $326,000.00-$460,000.00
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?
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offEquity / stock optionsPerformance bonusParental leave
Additional Information
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.
Biogen · San Francisco, CA