Vice President, Pharmacovigilance

🔥 14 minutes ago

🇺🇸 United States – Remote

💵 $330k - $410k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Immunic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

💼 Consulting

⚖️ Legal

Healthcare • Consulting • Legal

Immunic Therapeutics is a late-stage biotechnology company focused on developing novel, orally administered small-molecule therapies for chronic inflammatory and autoimmune diseases, with particular programs targeting multiple sclerosis and celiac disease. The company advances differentiated clinical-stage programs (e. g. , vidofludimus calcium, IMU-856, IMU-381) aiming to provide efficacious, safe, and well-tolerated oral treatment options for neurologic and gastrointestinal immune-mediated conditions, while pursuing regulatory protections and commercialization pathways.

📋 Description

• Establish and oversee pharmacovigilance strategy and operations to ensure patient safety • Develop and implement pharmacovigilance processes, policies, SOPs, and safety database/PV systems • Lead cross-functional governance, benefit-risk assessment, signal detection, and risk management efforts • Chair the executive safety review committee • Oversee safety data exchange with partners and contribute to industry-wide safety initiatives • Partner with clinical development to integrate safety into protocols, risk management plans, and safety charters • Provide PV oversight for IND/BLA/MAA regulatory filings, including Clinical Overviews, ISS, and RMPs • Review IBs, DSURs, and key CSR sections and participate in regulatory meetings as needed • Lead medical review of ICSRs and oversee PV team operations, quality, and compliance • Monitor and assess CRO performance on pharmacovigilance activities • Recruit, hire, train, mentor, and coach PV staff • Oversee project deliverables and performance evaluations

🎯 Requirements

• MD, with clinical and industry experience • Proven track record leading pharmacovigilance teams • Minimum of 15 years' experience in drug safety and pharmacovigilance roles in the biotech or pharmaceutical industry • Proven leadership expertise, including building and leading high-performing teams • In-depth knowledge of global pharmacovigilance regulations and compliance requirements (EMA/FDA/ICH) • Strong leadership and strategic decision-making abilities • Authorization to work in the US is requested in the application form

🏖️ Benefits

• Equity • Bonus • Equal Opportunity Employer commitment to a diverse, inclusive, and equitable workplace

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