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Senior Manager, Pharmacovigilance (Contractor) jobs in United States
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Eikon Therapeutics · 2 months ago

Senior Manager, Pharmacovigilance (Contractor)

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. They are seeking an experienced Senior Manager, Pharmacovigilance (Contractor) to manage safety data across their product portfolio and ensure compliance with regulatory requirements.
BiotechnologyHealth CareLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Pharmacovigilance expertiseRegulatory compliance knowledgeMS Office proficiencyOracle ARGUS Safety DatabaseAnalytical skillsCommunication skillsLeadership abilityExperience in oncologyExperience in rare diseasesDetail-orientedCollaboration skillsProblem-solving skills

Required

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

Preferred

Experience in oncology or rare diseases is a plus
Previous experience interacting with health authorities during inspections and audits

Company

Eikon Therapeutics

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Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.

H1B Sponsorship

Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)

Funding

Current Stage
Late Stage
Total Funding
$1.12B
Key Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M

Leadership Team

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Roger Perlmutter
Chairman, President, and CEO
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Michael Klobuchar
Chief Operating Officer
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Company data provided by crunchbase