Senior Manager, Pharmacovigilance

4 weeks ago

Jersey City, United States BioSpace Full time
Job Details

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.

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.

Key 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.
  • Manage safety data collection, processing, evaluation, and reporting in compliance with applicable regulations and guidelines.
  • Contribute to the preparation and review of safety sections of regulatory submissions.
  • Conduct safety surveillance activities, including signal detection (like performing analyses of safety information) and risk management.
  • 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:
  • Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations and processes.Strong understanding of global regulatory requirement related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.).
  • 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 in oncology or rare diseases is a plus.
  • Previous experience interacting with health authorities during inspections and audits.

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 $161,000 to $175,750 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.

In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

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.

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