Pharmacovigilance Lead - Clinical Safety & Compliance

Eikon Therapeutics; Jersey City (NJ); Sur place; USD 170 000 - 205 000; Plein temps

Avantages offerts par ce poste

401k plan with company matching

Medical (premiums covered by Eikon at

Mental health and wellness benefits

Weeklong summer and winter holiday SH

Generous paid time off and holiday pol

Life/AD&D Insurance (premiums covered)

Enhanced parental leave benefit

Daily subsidized lunch program when on

Résumé du poste

Eikon Therapeutics is seeking a Senior Manager, Pharmacovigilance to lead safety data management across our clinical portfolio in a highly collaborative environment. The role emphasizes proactive safety monitoring, cross-functional alignment, and regulatory-compliant processes in a fast-growth setting.

The position requires onsite presence in Jersey City, NJ at least three days per week, with opportunities to influence clinical development and lifecycle safety strategy while supporting a growing

Qualifications

• MD with 4+ years of experience in pharmacovigilance or drug safety.
• Strong understanding of global regulatory requirements related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.).
• Proven ability to lead and manage pharmacovigilance activities independently.
• Experience with safety databases and pharmacovigilance systems.
• Experience interacting with health authorities during inspections and audits.
• Experience in oncology or rare diseases is a plus.

Responsabilités

• Lead and manage pharmacovigilance activities for our clinical-stage programs.
• Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure the safety of our products.
• Oversee the development and maintenance of pharmacovigilance processes and procedures.
• ICSR Management: Safety mailbox management, safety data collection, end-to-end case processing (book in, triage, data entry, query generation, quality review, evaluation, medical review including narrative writing) and reporting in compliance with applicable regional regulations and guidelines.
• Generation and distribution of (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.

Description du poste

Eikon Therapeutics is seeking a Senior Manager, Pharmacovigilance to lead safety data management across our clinical portfolio in a highly collaborative environment. The role emphasizes proactive safety monitoring, cross-functional alignment, and regulatory-compliant processes in a fast-growth setting.

The position requires onsite presence in Jersey City, NJ at least three days per week, with opportunities to influence clinical development and lifecycle safety strategy while supporting a growing