[Remote] Senior Manager, Pharmacovigilance (Contractor) at Eikon Therapeutics

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Drug DiscoveryIndustries

Requirements

MD with 4+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations processes
Strong understanding of global regulatory requirements related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.)
Proven technical aptitude with MS Office and Oracle ARGUS Safety Database
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
Pharmacovigilance expert who is analytical, detail-oriented, collaborative, with uncompromising integrity, conscientious, obsessive attention to detail, documentation and organization skills, and self-starter

Responsibilities

Lead and manage pharmacovigilance activities for clinical-stage programs
Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure the safety of 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
Management of safety data across the portfolio of products
Proactively monitor and assess adverse events to ensure patient safety and compliance with regulatory requirements

Skills

Key technologies and capabilities for this role

PharmacovigilanceICSR ManagementSafety Data CollectionAdverse Event ReportingRegulatory ComplianceCase ProcessingMedical ReviewNarrative WritingSafety Mailbox ManagementCross-functional Collaboration

Questions & Answers

Common questions about this position

Is this a full-time employee position or a contract role?

This is a contractor position for Senior Manager, Pharmacovigilance.

What is the salary or compensation for this role?

This information is not specified in the job description.

What qualifications and skills are required for this position?

Candidates need an MD with 4+ years of pharmacovigilance or drug safety experience, strong knowledge of global regulations (FDA, EMA, ICH), proficiency in MS Office and Oracle ARGUS Safety Database, leadership ability, excellent communication, and detail-orientation.

What kind of company culture does Eikon Therapeutics have?

Eikon values collaboration, uncompromising integrity, conscientiousness, obsessive attention to detail, documentation, organization, and self-starters in a team-oriented environment focused on drug discovery.

What makes a strong candidate for this pharmacovigilance role?

A strong candidate is a pharmacovigilance expert with an MD and 4+ years experience, analytical and detail-oriented mindset, passion for drug discovery, strong regulatory knowledge, technical skills in ARGUS, and proven ability to lead independently while collaborating cross-functionally.

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

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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