Senior Manager, Pharmacovigilance
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, supporting patient safety, and ensuring compliance with regulatory requirements. The position leads pharmacovigilance activities for clinical-stage programs and works cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams. It also oversees pharmacovigilance processes and procedures, safety case management and reporting, and relationships with external vendors and partners. The role provides pharmacovigilance expertise for product development and lifecycle management and contributes to safety sections of regulatory submissions. The position requires onsite presence at Eikon's Jersey City, New Jersey office at least three days per week, or more as business needs require, to support effective management, operational excellence, clinical study delivery, and team collaboration.
Requirements
- MD and 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 aptitude 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.
- Detail-oriented, with strong analytical and problem-solving skills.
- Experience with safety databases and pharmacovigilance systems.
- Experience interacting with health authorities during inspections and audits.
Nice To Haves
- 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, safety data collection, end-to-end ICSR processing—including booking in, triage, data entry, query generation, quality review, evaluation, and medical review with narrative writing—and reporting in compliance with applicable regional regulations and guidelines.
- Generate and distribute periodic line listings to business partners.
- Contribute as needed to the preparation and review of safety sections of regulatory submissions.
- Coordinate and manage relationships with external vendors and partners involved in pharmacovigilance activities.
- Provide pharmacovigilance expertise and support for product development and lifecycle management activities.
Benefits
- 401(k) plan with company matching.
- Medical insurance, with premiums covered by Eikon at 95%.
- Dental insurance, with premiums covered by Eikon at 100%.
- Vision insurance, with 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, with premiums covered by Eikon at 100%, and optional supplemental employee-paid life and AD&D policies.
- Enhanced parental leave benefit.
- Daily subsidized lunch program when on-site.
- Bonus and equity compensation.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
