Director of Pharmacovigilance – Oncology (Remote)

Immuneering Corporation; New York (NY); Remote; USD 200,000 - 320,000; Full time

Benefits offered by this job

Fully remote work environment

Competitive compensation

Equity participation

Exceptional benefits

Job summary

Immuneering Corporation seeks an experienced Director, Pharmacovigilance to build and lead PV during a pivotal growth phase. You will shape end-to-end safety surveillance strategy across oncology programs, including global Phase 3, and be the internal PV expert across clinical, regulatory and medical affairs.

This high-impact role involves establishing PV systems, policies, and processes, overseeing safety data collection, and collaborating with PV CROs and partners to ensure regulatory

Qualifications

• MD required with leadership experience in pharmacovigilance.
• 5–8 years in PV with at least 1 year in a director role.
• Demonstrated expertise in global PV regulations and guidelines.
• Experience overseeing ICSR management and aggregate reporting.
• Oncology drug development experience and health authority interactions.
• Experience managing PV databases and safety data systems.
• Strong written and verbal communication skills.

Responsibilities

• Oversee safety data management and regulatory submission of ICSRs, SAEs, and SUSARs.
• Prepare DSURs, PSURs/PBRERs, and PADERs for global regulators.
• Lead reporting to health authorities and trials site compliance.
• Establish and run signal detection and risk management processes.
• Prepare safety sections for IBs, protocols, and informed consent forms.
• Collaborate with Clinical Ops, Regulatory, Data Mgmt, and Biostatistics.
• Manage PV vendor relationships, data exchange agreements, and audits.

Skills

Pharmacovigilance leadership

Global PV regulations

ICSR management

Signal detection

Safety data reporting

Excellent communication

Education

MD

Tools

Argus

ARISg

Oracle LSH

Job description

Immuneering Corporation seeks an experienced Director, Pharmacovigilance to build and lead PV during a pivotal growth phase. You will shape end-to-end safety surveillance strategy across oncology programs, including global Phase 3, and be the internal PV expert across clinical, regulatory and medical affairs.

This high-impact role involves establishing PV systems, policies, and processes, overseeing safety data collection, and collaborating with PV CROs and partners to ensure regulatory