Job details

Vice President, Drug Safety and Pharmacovigilance (DSPV)

Immunovant is a clinical-stage immunology company developing targeted anti-FcRn therapies to improve the lives of people with autoimmune diseases. The company is seeking an experienced global leader to establish and run a compliant, strategic Drug Safety and Pharmacovigilance function across pre- and post-marketing phases, interfacing with internal teams and regulatory authorities.

Skills

Extensive pharmacovigilance and drug safety expertise across development and commercial stages
Deep knowledge of FDA, EMA, ICH guidelines and global safety reporting requirements
Experience leading BLA-related safety activities and commercialization readiness
Strong medical judgment and ability to interpret clinical trial safety data
Proven ability to build and manage high-performing PV teams and vendors
Excellent communication and stakeholder engagement skills
Experience with risk management strategies and safety surveillance systems

Responsibilities

Develop, organize, manage and maintain a fully compliant global pharmacovigilance (PV) system
Own DSPV strategy and deliverables, including safety sections of clinical and regulatory documents (IBs, RSIs, ICFs, protocols, CSRs) and DSURs
Provide medical and scientific leadership for product safety and lifecycle risk-benefit assessments
Lead and grow the DSPV organization (operations and safety science) to support registrational and post-marketing activities
Serve as lead safety representative in regulatory interactions and internal governance
Oversee PV activities performed by external partners, vendors, and CROs
Ensure audit and inspection readiness for the DSPV function
Manage departmental planning, budgeting, and resource forecasting
Chair and lead safety committees and cross-functional safety meetings

Education

MD or equivalent clinical degree required
Additional training or experience in rare diseases preferred

Benefits

Equity and other variable compensation as part of total package
Medical, dental, and vision insurance
401(k) plan
Unlimited paid time off
Parental leave
Remote work
Domestic & international travel (approx. 10-20%)

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pharmacovigilance drug safety PV BLA regulatory risk management signal detection clinical safety post-marketing safety surveillance FDA ICH medical director VP immunology safety science

Average salary estimate

$412500 / YEARLY (est.)

min

max

$400000K

$425000K

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DEPARTMENTS

Research & Development

SENIORITY LEVEL REQUIREMENT

Director / Expert

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