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Medical Director, Pharmacovigilance
2 weeks ago
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 Medical Director, Pharmacovigilance, you will play a pivotal role in ensuring the safety and efficacy of our pharmaceutical products and clinical trials. Operating in a dynamic and collaborative environment, you will provide strategic leadership and oversight to 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 role is an experienced pharmacovigilance leader with exceptional leadership and team management skills. They possess a deep understanding of pharmacovigilance regulations and processes, ensuring that safety reporting and risk mitigation activities are executed with precision and compliance. Their strong organizational and communication skills, along with meticulous attention to detail and analytical abilities, enable them to maintain high-quality standards, oversee vendor relationships, provide education to internal teams, and uphold comprehensive documentation while staying updated on evolving regulations and standards. Their proficiency in pharmacovigilance tools and software, coupled with their ability to collaborate with cross-functional teams, ensures that pharmacovigilance activities align with project goals and timelines.
What You'll Do
- Pharmacovigilance Leadership: Provide strategic leadership and oversee all aspects of 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.
- ICSR Management: Proficient in case processing, quality checks (QC), medical review and medical approval of adverse event cases, including SAEs, AESI, SUSAR reports.
- Signal Detection (in collaboration with the Clinical Safety team): Utilize pharmacovigilance data to identify potential safety signals, assess risks, and contribute to the development of risk mitigation strategies.
- 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.
- Cross-functional 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 and a minimum of 7+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations and processes.
- Managerial experience required.
- Exceptional leadership and team management skills.
- 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 $239,000 to $261,250 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.
