Director, Pharmacovigilance Operations

Job not on LinkedIn

🔥 12 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🔴 Lead

⚙️ Operations

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Altimmune, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 1997

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Altimmune is a late-stage clinical biopharmaceutical company focused on developing therapies for serious liver diseases. The company’s pipeline targets conditions with high unmet need including metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). Its lead candidate, pemvidutide, is an investigational therapy designed to address liver disease via glucagon receptor activity and metabolic effects through GLP-1 activity. Altimmune advances treatments by addressing fundamental mechanisms driving liver disease progression.

📋 Description

• Provide day-to-day oversight of the company's Pharmacovigilance system and delegated PV activities • Oversee global pharmacovigilance activities, including case processing, reporting, literature surveillance, safety data reconciliations, and outsourced PV services • Review safety data for quality, completeness, and consistency across clinical studies • Monitor PV performance metrics, quality indicators, quality trends, and compliance metrics • Identify, investigate, and escalate PV compliance issues • Support implementation of new products, partners, and business initiatives affecting PV activities • Lead oversight of PV vendors, CROs, license partners, patient-support service providers, and other external parties • Maintain vendor performance and contractual/PVA obligations and coordinate governance reviews • Coordinate inspection readiness, regulatory inspections, vendor audits, inspection responses, commitments, and follow-up activities • Support the pharmacovigilance quality framework and monitor deviations, quality events, CAPAs, audits, inspections, and corrective actions • Oversee PV training governance and maintain PV procedures, work instructions, governance records, and evidence repositories • Support development, implementation, and maintenance of Pharmacovigilance Agreements and partner governance documents • Serve as operational liaison and PV project manager between Pharmacovigilance and internal stakeholders • Lead PV governance meetings, coordinate cross-functional safety deliverables and timelines, and present compliance trends, risks, and recommendations to PV leadership • Support strategic initiatives and organizational change activities impacting the PV system

🎯 Requirements

• Bachelor's degree, preferably in a science or health-related field • Pharmaceutical industry background and proven competence in pharmacovigilance • Demonstrated experience with vendor oversight, PV Agreements, compliance monitoring, inspection readiness, regulatory reporting requirements, quality systems, and CAPA management • Knowledge of FDA, ICH, and global pharmacovigilance requirements • Experience supporting FDA inspections • Minimum of 10+ years of experience in Drug Safety/PV operations in the biotech industry • Experience within specialty pharmaceutical, biotechnology, or highly outsourced pharmacovigilance environments • Deep knowledge of PV science, operations, and global PV regulations • Knowledge of PV regulations and compliance, vendor governance, inspection readiness, quality systems, risk management, PV agreements, compliance metrics, and oversight • Strong analytical, communication, organizational, and project management skills

🏖️ Benefits

• Work from home flexibility • Hybrid or remote work arrangement depending on location • Travel as business needs dictate