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Immunome, Inc. · 4 days ago

Vice President, Pharmacovigilance & Drug Safety

Bothell, WA

Full-time

Onsite

Director/Executive

$364K/yr - $433K/yr

10+ years exp

Immunome, Inc. is a clinical-stage targeted oncology company focused on developing innovative cancer therapies. The Vice President, Pharmacovigilance & Drug Safety will lead the global safety strategy, ensuring compliance and overseeing drug safety operations across the company's pipeline.

BiopharmaBiotechnologyMedicalPharmaceutical

Responsibilities

Develop and implement the pharmacovigilance strategy in alignment with regulatory requirements and company goals

Build and develop a team of drug safety professionals to evaluate and oversee safety reporting and management

Oversee the collection, analysis, and reporting of safety data from ongoing clinical trials

Oversee the development of drug safety databases and reporting procedures to ensure regulatory compliance

Lead the preparation and submission of safety reports, including Periodic Safety Update Reports and other regulatory filings

Lead the safety analysis for regulatory submissions including NDAs, BLAs and MAAs

Ensure compliance with global regulatory requirements and guidelines, including those from the FDA, EMA, and ICH

Collaborate with Clinical Development, Regulatory Affairs, and Quality Assurance teams to ensure integrated approaches to drug safety. Provide expert safety guidance during development of protocols and other site-facing documents

Provide expert guidance on risk management and mitigation strategies throughout the product lifecycle

Conduct regular training for staff on pharmacovigilance practices and regulatory updates

Analyze safety data trends and provide actionable insights to senior management and stakeholders

Represent the pharmacovigilance function in meetings with regulatory authorities and during audits

Provide medical expertise to clinical teams in evaluation of safety events

Qualification

PharmacovigilanceDrug SafetySignal DetectionRisk ManagementRegulatory ComplianceData AnalysisLeadershipCommunication SkillsInterpersonal SkillsProblem-Solving Skills

Required

M.D., D.O., or equivalent advanced degree in life sciences or pharmacology required; additional training in oncology or drug safety highly preferred

A minimum of 10 years of pharmacovigilance and drug safety experience in biotech and/or pharmaceutical settings, including a minimum of 5 years in a senior leadership role with global responsibilities

Strong knowledge of global pharmacovigilance regulations and industry standards. Deep expertise in global pharmacovigilance regulations (FDA, EMA, ICH, MHRA, PMDA) and evolving industry best practices

Proven track record of managing safety data and conducting signal detection and risk assessment. Proven ability to lead signal detection, aggregate safety data review, benefit–risk assessment, and implementation of proactive risk management strategies

Demonstrated ability to build a highly functioning team. Demonstrated success in building, mentoring, and scaling high‑performing global pharmacovigilance and drug safety teams

Excellent communication, leadership, and interpersonal skills

Ability to work collaboratively in a fast-paced, dynamic environment

Strong analytical and problem-solving skills

Company

Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

Founded in 2008

Exton, Pennsylvania, USA

51-200 employees