Senior Manager, Pharmacovigilance

The role

The Senior Manager, Pharmacovigilance will manage safety data across a portfolio of products. This role involves monitoring adverse events and working cross-functionally to ensure regulatory compliance.

What you will do

• Lead and manage pharmacovigilance activities for clinical-stage programs.
• Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams.
• Oversee the development and maintenance of pharmacovigilance processes and procedures.
• Manage safety mailbox, data collection, end-to-end case processing, and reporting.
• Generate and distribute periodic line listings to business partners.
• Contribute to the preparation and review of safety sections of regulatory submissions.
• Coordinate and manage relationships with external vendors and partners.
• Provide pharmacovigilance expertise for product development and lifecycle management.

Required qualifications

• MD with 4+ years of experience in pharmacovigilance or drug safety.
• Strong understanding of pharmacovigilance regulations processes.
• Strong understanding of global regulatory requirement related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.).
• Proven technical aptitude with MS Office and Veeva Safety Database.
• Proven ability to lead and manage pharmacovigilance activities independently.
• 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 have

• Experience in oncology or rare diseases

Benefits

• 401k 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/AD&D Insurance (premiums covered by Eikon at 100%)
• Optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

About the company

Eikon Therapeutics is a biopharmaceutical company using technology at the intersection of chemistry, engineering, computation, and biology to discover treatments for life-threatening diseases.