Senior Manager, Pharmacovigilance

About the role

We are seeking an experienced Senior Manager, Pharmacovigilance to join our team. The Senior Manager, Pharmacovigilance will be responsible for the management of safety data across our portfolio of products. The successful candidate will play a critical role in ensuring the safety of our patients by proactively monitoring and assessing adverse events, as well as working cross-functionally to ensure compliance with regulatory requirements. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City, NJ office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

Responsibilities

• 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

Qualifications

• MD with 4+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations 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 is 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

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%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

Pay

The expected salary range for this role is $170,000 to $204,750 depending on skills, competency, and the market demand for your expertise. Employee compensation also includes bonus and equity compensation.

Schedule

Minimum 3 days per week onsite in Jersey City, NJ office (or more as business needs require).