Pharmacovigilance Clinician
Hippocratic AISalary not specified
Full Time
Expert & Leadership (9+ years)
Medical Director, Pharmacovigilance at Eikon Therapeutics
Jersey City, New Jersey, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biopharmaceutical, PharmaceuticalIndustries
Requirements
- MD degree
- Minimum of 7+ years of experience in pharmacovigilance or drug safety
- Strong understanding of pharmacovigilance regulations and processes
- Exceptional leadership and team management skills
- Strong organizational and communication skills
- Meticulous attention to detail and analytical abilities
- Proficiency in pharmacovigilance tools and software
- Ability to collaborate with cross-functional teams
- Minimum of 3 days a week onsite presence in New Jersey office (or more as business needs require)
Responsibilities
- Provide strategic leadership and oversee all aspects of pharmacovigilance activities, including collection, assessment, and reporting of adverse events
- Ensure timely and accurate reporting of adverse events to regulatory authorities in compliance with global pharmacovigilance regulations
- Manage ICSR processing, including quality checks (QC), medical review, and medical approval of adverse event cases, SAEs, AESI, and SUSAR reports
- Utilize pharmacovigilance data for signal detection (in collaboration with Clinical Safety team), assess risks, and contribute to risk mitigation strategies
- Maintain high standards of quality and compliance in pharmacovigilance activities, adhering to internal processes and SOPs
- Collaborate with external vendors and partners for effective communication and oversight
- Provide pharmacovigilance training and education to internal teams and stakeholders
- Maintain accurate and comprehensive pharmacovigilance records and documentation
- Stay informed about evolving pharmacovigilance regulations and industry standards to ensure ongoing compliance
- Collaborate closely with cross-functional teams (e.g., clinical, regulatory affairs) to align pharmacovigilance with project goals and timelines
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this role remote or does it require office presence?
The role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in the New Jersey office to ensure effective management, operational excellence, and collaboration.
What are the key skills required for the Medical Director, Pharmacovigilance role?
Key skills include exceptional leadership and team management, deep understanding of pharmacovigilance regulations and processes, strong organizational and communication skills, meticulous attention to detail, analytical abilities, and proficiency in pharmacovigilance tools and software.
What does the work environment look like at Eikon Therapeutics?
The environment is dynamic and collaborative, with a focus on strategic leadership, cross-functional team collaboration, and supporting significant team growth.
What experience makes a strong candidate for this position?
A strong candidate is an experienced pharmacovigilance leader skilled in overseeing safety reporting, ICSR management, signal detection, and quality assurance, with the ability to manage teams, vendors, and ensure regulatory compliance.
What is the salary or compensation for this role?
This information is not specified in the job description.
Eikon Therapeutics
Biotech startup developing innovative medicines
About Eikon Therapeutics
Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.
Hayward, CaliforniaHeadquarters
2019Year Founded
$750.8MTotal Funding
SERIES_CCompany Stage
AI & Machine Learning, BiotechnologyIndustries
201-500Employees