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Salary: USD 170,000 - 204,750 / annual
Eikon Therapeutics is a biopharmaceutical company leveraging revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The company's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), including microscopes that enable real-time, molecular-resolution measurements of protein movement in living cells, unlocking otherwise intractable classes of proteins as drug targets.
The Senior Manager, Pharmacovigilance will lead and manage safety data across Eikon's portfolio of products, playing a critical role in ensuring patient safety by proactively monitoring and assessing adverse events while ensuring compliance with regulatory requirements. This role requires a minimum of 3 days per week onsite in Jersey City, NJ, with flexibility for additional presence as business needs require.
Key responsibilities include:
- Leading and managing pharmacovigilance activities for clinical-stage programs
- Collaborating cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure product safety
- Overseeing development and maintenance of pharmacovigilance processes and procedures
- Managing ICSR (Individual Case Safety Report) activities: 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
- Generating and distributing periodic line listings to business partners
- Contributing to preparation and review of safety sections of regulatory submissions
- Coordinating and managing relationships with external vendors and partners involved in pharmacovigilance activities
- Providing pharmacovigilance expertise and support for product development and lifecycle management activities
The ideal candidate is analytical, detail-oriented, and has an appreciation for compliance. You are collaborative by nature with uncompromising integrity, conscientious, and pay obsessive attention to detail. Documentation and organization are second nature. You are a self-starter.
QUALIFICATIONS:
- MD with 4+ years of experience in pharmacovigilance or drug safety, with strong understanding of pharmacovigilance regulations and processes
- Strong understanding of global regulatory requirements related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.)
- Proven technical aptitude with MS Office and Veeva Safety Database (required)
- 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
- Experience in oncology or rare diseases is a plus
