Head of PV & Drug Safety, West Coast Hub jobs in United States
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Biogen · 1 day ago

Head of PV & Drug Safety, West Coast Hub

Biogen is a mid-sized biotechnology company committed to excellence and innovation. They are seeking a Head of Drug Safety & Pharmacovigilance for the West Coast Hub to ensure the safety and efficacy of therapies focused on immune-mediated diseases, overseeing safety science, clinical surveillance, and regulatory safety engagement.

BiotechnologyHealth CareNeuroscienceTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

PharmacovigilanceDrug SafetyGlobal PV RegulationsAnalytical SkillsSafety DatabasesExecutive PresenceCommunication SkillsTeam Leadership

Required

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

Advanced training in pharmacoepidemiology or MPH
Experience supporting immune-mediated or rare diseases

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

Company

Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.

H1B Sponsorship

Biogen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)

Funding

Current Stage
Public Company
Total Funding
$1.5B
Key Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO

Leadership Team

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Robin C. Kramer
Executive Vice President, Chief Financial Officer
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Priya Singhal
Executive Vice President, Head of Development
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Company data provided by crunchbase