[Remote] Senior Manager, Pharmacovigilance (Contractor)

Note:The job is a remote job and is open to candidates in USA. Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. They are seeking an experiencedSenior Manager, Pharmacovigilance (Contractor) to manage safety data across their product portfolio and ensure compliance with regulatory requirements. 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. Skills• 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. Company Overview• Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.It was founded in 2019, and is headquartered in Hayward, California, USA, with a workforce of 201-500 employees. Its website isCompany H1B Sponsorship• Eikon Therapeutics has a track record of offering H1B sponsorships, with 10 in 2025, 19 in 2024, 7 in 2023, 3 in 2022, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job