Senior Manager, Pharmacovigilance

Eikon Therapeutics; Jersey City (NJ); On-site; USD 170,000 - 205,000; Full time

Benefits offered by this job

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

Job summary

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.

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.

Job description

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

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 day 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.

About You

You are a Pharmacovigilance expert with a passion for drug discovery. You are an analytical, detail-oriented, and you have an appreciation for compliance. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature. You are a self-starter in spirit.

What You’ll Do

• 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 requirement 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.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

• 401k plan with company matching
• Medical (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

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

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

As set forth in Eikon Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.