Head of PV & Drug Safety, West Coast Hub
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Job Location:
San Francisco, CA - USA
Monthly Salary:
$ 281000 - 387000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 tomaintainthe integrity of our global safety surveillance activities. Your role is essential in safeguarding patient well-being andoptimizingthe 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 thatexpeditethe delivery of impactful medicines.
WhatYoullDo:
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 safetyremainsa 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.
Proficiencywith safety databases and analytics platforms.
Domestic and international travel may be.
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 $10000 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 onto 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.
Required Experience:
Director
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About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
