Head of PV & Drug Safety, West Coast Hub
About The Position
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.
Requirements
- 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.
Nice To Haves
- Advanced training in pharmacoepidemiology or MPH.
- Experience supporting immune-mediated or rare diseases.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
