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 (Contractor) to join our team. The Senior Manager, Pharmacovigilance (Contractor) 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.
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 Oracle ARGUS 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 in oncology or rare diseases is a plus.
- Previous experience interacting with health authorities during inspections and audits.
The expected hourly range for this role is $79/hour to $87/hour depending on skills, competency, and the market demand for your expertise. This is a contract role, expected to last approximately 3 months, with an anticipated workload of 40 hours per week.
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.
Top Skills
What We Do
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.
By directly measuring the effects of chemical compounds on the behavior of protein molecules in a live cellular environment, Eikon’s landmark assays facilitate the highly sensitive identification of compound-protein interactions that could not be identified through traditional assays, thereby unlocking otherwise intractable classes of proteins as drug targets. Furthermore, the ability to directly visualize protein mechanisms in disease coupled with the extraordinarily high-powered high-content data sets generated by Eikon’s drug-screening technology enable an unprecedented opportunity to quantitatively explore novel biology in the living cell. These insights facilitate creation and application of data-driven hypotheses to the discovery of life-saving therapies.
Eikon is seeking adventurous, passionate and creative team members eager to apply their talents to empower interdisciplinary scientific exploration, inaugurate a radical drug-discovery paradigm, and ultimately create novel medicines. To learn more about open positions, please visit: https://eikontx.com/team#positions
