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General Manager
Chipotle Services, LLC
United States
…Cultivating a Better World while sharpening your leadership and operations skills along the way. If building teams and growing a business excites you, keep reading to learn…
Added just now
General Manager
Chipotle Services, LLC
United States
…Cultivating a Better World while sharpening your leadership and operations skills along the way. If building teams and growing a business excites you, keep reading to learn…
Added just now
General Manager
Chipotle Services, LLC
United States
…Cultivating a Better World while sharpening your leadership and operations skills along the way. If building teams and growing a business excites you, keep reading to learn…
Added just now
Assistant General Manager
Chipotle Services, LLC
United States
…to grow into General Managers by assisting in the day-to-day operations of our restaurants. You’ll learn what it takes to run a strong business, hire and train great people, and deliver a…
Added just now
General Manager
Chipotle Services, LLC
United States
…Cultivating a Better World while sharpening your leadership and operations skills along the way. If building teams and growing a business excites you, keep reading to learn…
Added just now
Assistant General Manager
Chipotle Services, LLC
United States
…to grow into General Managers by assisting in the day-to-day operations of our restaurants. You’ll learn what it takes to run a strong business, hire and train great people, and deliver a…
Added just now
Assistant General Manager
Chipotle Services, LLC
United States
…to grow into General Managers by assisting in the day-to-day operations of our restaurants. You’ll learn what it takes to run a strong business, hire and train great people, and deliver a…
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E-Commerce Marketing Manager
BLUE CHIP GROUP LLC
Salt Lake City, UT
The E-Commerce Marketing Manager oversees digital marketing initiatives, agency relationships, online merchandising, marketplace optimization, and performance analytics while collaborating…
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Manager Procurement Center of Excellence
Schindler Group
Hanover (Logistic Ctr), PA
The Procurement Center of Excellence (CoE) Manager is responsible for driving procurement excellence
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Manager, Merchandising Operations
The RealReal, Inc.
Secaucus 35, NJ
…goods, with 40 million members. With a rigorous authentication process overseen by experts, The RealReal provides a safe and reliable platform for consumers to buy and sell their luxury…
Added 1 min ago
Software Engineering Manager
NCR VOYIX
ATLANTA, GA
As a Manager, Software Engineering at NCR VOYIX, you will lead a team of talented software engineers in the design, development, and delivery of innovative software solutions. You will be…
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Assistant Manager
VIOC
Abilene, TX
- $19.5 USD / hour
When you join us as an Assistant Service Center Manager, you are the right hand of the Service Center Manager. You are responsible for taking the lead in helping build a high-performance…
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Assistant Manager
VIOC
Abilene, TX
- $19.5 USD / hour
When you join us as an Assistant Service Center Manager, you are the right hand of the Service Center Manager. You are responsible for taking the lead in helping build a high-performance…
Added 2 mins ago
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Assistant Manager
VIOC
Tallmadge, OH
- $21.25 USD / hour
When you join us as an Assistant Service Center Manager, you are the right hand of the Service Center Manager. You are responsible for taking the lead in helping build a high-performance…
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Assistant Manager
VIOC
Rockford, MI
- $22 USD / hour
When you join us as an Assistant Service Center Manager, you are the right hand of the Service Center Manager. You are responsible for taking the lead in helping build a high-performance…
Added 2 mins ago
Chief Information Security Officer (CISO)
U.S. Air Force - Agency Wide
Pentagon, VA
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Asst Food Service Director - NEX
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Catawba, VA
…director to our [Segment] team in [City]. As an assistant food service director, you will have the opportunity to assist with overseeing all culinary, safety and sanitation, and operations…
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Logistics Operations Manager | Customer On-Site
Expeditors
Charlotte, NC
Based at the customer site in China Grove, the Logistics Operations Manager will work with business leads to define and manage business process and technology roadmaps, manage change…
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SR CHEF MANAGER - CHESTER, VA
Compass Group, North America
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Working as the Chef Manager Senior you will be responsible for back and front of the house operations for the food service departments. You will maintain a quality culinary program and…
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Facilities Supervisor
CBRE
Midlothian, VA
- From $84,500 USD / year
…sales, debt origination, mortgage serving, valuations); Building Operations & Experience (facilities management, property management, flex space & experience); Project Management (program…
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Branch Operations Manager, Floorcovering
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The Branch Operations Manager works with the Branch Manager to organize, plan, and implement strategies in a Sherwin-Williams floorcovering branch. This includes supporting all aspects of…
Added 3 mins ago
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Proposal Manager
Curtiss-Wright Corporation
Ashburn, VA
- $130,800 to $145,000 USD / year
Reporting to the Director, Proposals Solutions in the Sales Operations group, the position focuses on supporting multiple business units within a Shared Service environment. The successful…
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Infusion Nurse Clinical Liaison
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…with infusion nurses, pharmacists, referral hub staff, and operations leaders to improve access, patient experience and clinical…
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CORPORATE FINANCIAL PLANNING & ANALYSIS ANALYST 3
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Altimmune

Director, Pharmacovigilance Operations

Morristown, NJ, United States

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Job details

Experience: A minimum of 10+ years of experience in Drug Safety/PV operations in the biotech industry
Posting language: English
Posted: Oct 14, 2026

Original job description

Altimmune (NASDAQ: ALT) is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company's lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.

Summary of Position:

The Director, Pharmacovigilance Operations provides day-to-day oversight of the company's Pharmacovigilance (PV) System and ensures delegated PV activities comply with applicable regulatory requirements, company procedures, and partner obligations.

This position serves as the operational governance lead for the PV system and oversees vendors, inspection readiness, compliance monitoring, training governance, PV agreement implementation, quality oversight activities, and key pharmacovigilance governance processes. Partners cross-functionally with Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial, Clinical, and external service providers to drive regulatory strategy, execution, and compliance.

This position reports to the Senior Director, Safety and Pharmacovigilance, and, depending on location, may be hybrid or remote and may require travel as business needs dictate.

Essential Functions:

PV Operations Oversight:

Provide oversight of delegated global pharmacovigilance activities, including case processing, reporting, literature surveillance, safety data reconciliations, and other outsourced PV services.
Safety data review for quality, completeness, and consistency across clinical studies
Monitor PV performance metrics, key quality indicators, quality trends, and compliance metrics
Identify, investigate, and escalate actual or potential PV compliance issues.
Coordinate review and follow-up of operational trends and performance indicators.
Support implementation of new products, partners, and business initiatives affecting PV activities.

Vendor and Partner Governance

Lead oversight of PV vendors, CROs, license partners, patient-support service providers, and other external parties.
Maintain oversight of vendor performance and contractual/PVA obligations.
Coordinate periodic governance reviews and performance discussions.
Escalate significant compliance, quality, or operational concerns.
Support due diligence, onboarding, transition, and oversight activities for new vendors and partners.

Inspection Readiness and Compliance

Coordinate ongoing inspection-readiness activities.
Maintain readiness for FDA, Health Canada, partner, and internal audits.
Support regulatory inspections and vendor audits.
Coordinate inspection responses, commitments, and follow-up activities.
Maintain inspection-support materials and evidence retrieval processes.

PV Quality System Oversight

Support implementation and maintenance of the pharmacovigilance quality framework.
Monitor deviations, quality events, CAPAs, audits, inspections, and corrective actions.
Support periodic review of PV system health and compliance trends.
Participate in risk assessments and continuous improvement initiatives.

Training and Controlled Documentation

Oversee PV training governance processes.
Ensure appropriate training requirements are established and maintained for personnel and applicable external parties.
Support maintenance of PV procedures, work instructions, governance records, and related documentation.
Ensure inspection-ready documentation and evidence repositories are maintained.

PV Agreements and Governance Processes

Support development, implementation, and maintenance of Pharmacovigilance Agreements (PVAs) and related partner governance documents.
Monitor obligations arising from PVAs and related contracts.
Coordinate periodic reviews and updates of partner oversight documentation.

Leadership and Cross-Functional Collaboration

Serve as primary operational liaison and PV project manager between Pharmacovigilance and internal stakeholders.
Provide leadership for PV governance meetings and oversight reviews and coordinate cross-functional safety deliverables and timelines
Present compliance trends, risks, and recommendations to PV leadership
Support strategic initiatives and organizational change activities impacting the PV system

Job Requirements (essential knowledge, skills, and attributes):

Bachelor's degree, preferably in a science or health-related field; with 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
A 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
Technical: 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

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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More about this job

Skills

Good laboratory practices
Regulatory affairs
Reporting
Account reconciliation
Regulatory compliance
Inspection
Internal auditing
Process improvement
Documentation
Leadership
Pharmaceutical industry
Quality control systems
Biotechnology
Risk management
Communication skills
Project management

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