Senior Manager, Pharmacovigilance

Eikon Therapeutics•Jersey City, NJ

19h•Hybrid

About The Position

Eikon Therapeutics is seeking an experienced Senior Manager, Pharmacovigilance to manage safety data across its product portfolio. The role is responsible for proactively monitoring and assessing adverse events and working cross-functionally to ensure compliance with regulatory requirements, while supporting patient safety and clinical-stage programs. The position requires at least three days per week onsite at the company’s Jersey City, New Jersey office, or more often as business needs require. The onsite presence supports effective management, operational excellence, high-performance delivery of clinical studies, team growth, and collaboration.

Requirements

MD degree.
At least 4 years of experience in pharmacovigilance or drug safety.
Strong understanding of pharmacovigilance regulations and processes.
Strong understanding of global pharmacovigilance regulatory requirements and guidelines, including FDA, EMA, and ICH.
Technical proficiency with MS Office and Veeva Safety Database.
Proven ability to independently lead and manage pharmacovigilance activities.
Excellent communication skills and ability to collaborate effectively across multidisciplinary teams.
Strong attention to detail, analytical skills, and problem-solving skills.
Experience with safety databases and pharmacovigilance systems.

Nice To Haves

Experience interacting with health authorities during inspections and audits.
Experience in oncology or rare diseases.

Responsibilities

Lead and manage pharmacovigilance activities for clinical-stage programs.
Collaborate with clinical development, regulatory affairs, medical affairs, and other teams to ensure product safety.
Oversee the development and maintenance of pharmacovigilance processes and procedures.
Manage safety mailboxes and safety data collection.
Manage end-to-end individual case safety report (ICSR) processing, including case intake, triage, data entry, query generation, quality review, evaluation, medical review, and narrative writing.
Ensure safety case processing and reporting comply with applicable regional regulations and guidelines.
Generate and distribute periodic line listings to business partners.
Contribute to the preparation and review of safety sections of regulatory submissions as needed.
Coordinate and manage relationships with external vendors and partners involved in pharmacovigilance activities.
Provide pharmacovigilance expertise and support for product development and lifecycle management.

Benefits

Bonus and equity compensation.
401(k) plan with company matching.
Medical insurance premiums covered by Eikon at 95%.
Dental and vision insurance premiums covered by Eikon at 100%.
Mental health and wellness benefits.
Weeklong summer and winter holiday shutdowns.
Generous paid time off and holiday policies.
Life and AD&D insurance premiums covered by Eikon at 100%, with optional supplemental employee-paid life and AD&D policies.
Enhanced parental leave benefit.
Daily subsidized lunch program when onsite.