Associate Director, Pharmacovigilance

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
As the Associate Director, Pharmacovigilance, you will play a critical role in ensuring the safety and efficacy of our pharmaceutical products and clinical trials. Operating in a dynamic and collaborative environment, you will lead pharmacovigilance activities, contributing significantly to the successful execution of our research and development initiatives.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey 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
The ideal candidate for this position should possess extensive experience and leadership in pharmacovigilance, with a strong understanding of regulatory compliance and a focus on maintaining high-quality standards. They should have the ability to detect potential safety signals, oversee safety reporting, and effectively manage vendor relationships. Additionally, their skills in training and education are crucial for promoting a culture of safety within the organization and ensuring compliance with evolving pharmacovigilance regulations and industry standards. Strong organizational, analytical, and communication skills are essential for success in this role.

What You'll Do

• Pharmacovigilance Leadership: Lead and oversee pharmacovigilance activities, including the collection, assessment, and reporting of adverse events associated with our products.
• Safety Reporting: Ensure timely and accurate reporting of adverse events to regulatory authorities in compliance with global pharmacovigilance regulations.
• Signal Detection: Utilize pharmacovigilance data to identify potential safety signals, assess risks, and contribute to risk mitigation strategies.
• Safety Data Analysis: Reviewing and assessing adverse event reports and other safety data to identify trends or signals.
• Safety Risk Management: Overseeing the development and execution of Risk Management Plans (RMPs), Risk Evaluation and Mitigation/minimization Strategies (REMS), and other safety monitoring strategies.
• Expert Safety Input: Providing expert safety input to clinical development programs and trials, including study documents such as DSUR, IB, and CSR.
• Drug Safety Review Committee: Leading Drug Safety Review Committee meetings for signal detection and risk evaluation.
• Quality Assurance: Maintain high standards of quality and compliance in pharmacovigilance activities, including adherence to internal processes and standard operating procedures.
• Vendor Management: Collaborate with external vendors and partners involved in pharmacovigilance activities, ensuring effective communication and oversight.
• Training and Education: Provide pharmacovigilance training and education to internal teams and stakeholders to promote a culture of safety.
• Documentation: Maintain accurate and comprehensive pharmacovigilance records and documentation.
• Regulatory Compliance: Stay informed about evolving pharmacovigilance regulations and industry standards, ensuring ongoing compliance.
• Collaboration: Collaborate closely with cross-functional teams, including clinical teams, regulatory affairs professionals, and other stakeholders to align pharmacovigilance activities with project goals and timelines.

Qualifications

• MD with 5+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations processes.
• Proven experience with medical review and case assessment/processing required.
• Excellent organizational and communication skills.
• Strong attention to detail and analytical abilities.
• Proficiency in pharmacovigilance databases and software.
• Capability to thrive in a fast-paced and collaborative work environment.
• Knowledge of clinical research, regulatory requirements, and biotechnology is advantageous but not required.

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 $196,000 to $213,750 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.