Director, Pharmacovigilance

Immuneering Corporation

Director of Pharmacovigilance at Immuneering leading safety surveillance strategies across oncology programs. Building the PV function at a clinical-stage biopharmaceutical company.

Posted 7/9/2026full-timeRemote • 🇺🇸 United StatesLead💰 $280,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance, including safety data management, regulatory compliance, and signal detection processes. Proven leadership in managing cross-functional teams and fostering a culture of patient safety within the biopharmaceutical industry.

Highest-signal resume keywords

M.D.Pharmacovigilance ExperienceGlobal PV Regulations ExpertiseOncology Drug Development ExperiencePV Safety Database Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ICSR ManagementAggregate Report AuthorshipSignal DetectionBenefit-Risk AssessmentsRegulatory Submissions

Soft Skills

Excellent Written CommunicationExcellent Verbal Communication

Tools & Technologies

ArgusARISgOracle LSH

Industry Keywords

PharmacovigilanceBiopharmaceutical IndustryFDA 21 CFR Parts 312/314/600EMA Good Pharmacovigilance PracticeICH E2A/E2D/E2E/E6

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

Build and lead the pharmacovigilance (PV) function at Immuneering
Oversee safety data management & reporting including ICSR processing and regulatory submissions
Establish formal signal detection and risk management processes
Collaborate with cross-functional teams including Clinical Operations and Regulatory Affairs
Manage vendor relations and ensure compliance with safety data obligations
Foster a culture of patient safety and prepare/manage a PV department budget

Requirements

What you’ll need

M.D. required
Minimum 5-8 years of pharmacovigilance experience in the biopharmaceutical industry, with at least 1 years in a leadership or director-level role
Demonstrated expertise in global PV regulations and guidelines (FDA 21 CFR Parts 312/314/600, EMA Good Pharmacovigilance Practice, ICH E2A/E2D/E2E/E6)
Experience overseeing all aspects of ICSR management, aggregate report authorship, and signal detection
Oncology drug development experience, including familiarity with oncology-specific safety profiles
Track record of successful health authority interactions on PV matters
Experience managing or overseeing PV safety databases (e.g., Argus, ARISg, Oracle LSH)
Strong scientific acumen with the ability to independently conduct and communicate benefit-risk assessments
Excellent written and verbal communication skills; ability to distill complex safety information for diverse audiences

Benefits

Comp & perks

Competitive compensation
Equity participation
Exceptional benefits
Fully remote work environment
Flexible, results-oriented culture