[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 experienced Senior Manager, Pharmacovigilance (Contractor) to manage safety data across their product portfolio and ensure compliance with regulatory requirements.
Responsibilities
ā¢ Lead and manage pharmacovigilance activities for our clinical-stage programs.
ā¢ Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure the safety of our products.
ā¢ Oversee the development and maintenance of pharmacovigilance processes and procedures.
ā¢ 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.
ā¢ Generation and distribution of (periodic) line listings to business partners.
ā¢ Contribute as needed to the preparation and review of safety sections of regulatory submissions.
ā¢ Coordinate and manage relationships with external vendors and partners involved in pharmacovigilance activities.
ā¢ Provide pharmacovigilance expertise and support for product development and lifecycle management activities.
Skills
ā¢ MD with 4+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations processes.
ā¢ Strong understanding of global regulatory requirement related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.).
ā¢ Proven technical aptitude with MS Office and Oracle ARGUS Safety Database is required.
ā¢ Proven ability to lead and manage pharmacovigilance activities independently.
ā¢ Excellent communication skills and ability to collaborate effectively across multidisciplinary teams.
ā¢ Detail-oriented with strong analytical and problem-solving skills.
ā¢ Experience with safety databases and pharmacovigilance systems.
ā¢ Experience in oncology or rare diseases is a plus.
ā¢ Previous experience interacting with health authorities during inspections and audits.
Company Overview
ā¢ 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 is http://www.eikontx.com.
Company H1B Sponsorship
ā¢ 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 Now
Apply Now
Responsibilities
ā¢ Lead and manage pharmacovigilance activities for our clinical-stage programs.
ā¢ Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure the safety of our products.
ā¢ Oversee the development and maintenance of pharmacovigilance processes and procedures.
ā¢ 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.
ā¢ Generation and distribution of (periodic) line listings to business partners.
ā¢ Contribute as needed to the preparation and review of safety sections of regulatory submissions.
ā¢ Coordinate and manage relationships with external vendors and partners involved in pharmacovigilance activities.
ā¢ Provide pharmacovigilance expertise and support for product development and lifecycle management activities.
Skills
ā¢ MD with 4+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations processes.
ā¢ Strong understanding of global regulatory requirement related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.).
ā¢ Proven technical aptitude with MS Office and Oracle ARGUS Safety Database is required.
ā¢ Proven ability to lead and manage pharmacovigilance activities independently.
ā¢ Excellent communication skills and ability to collaborate effectively across multidisciplinary teams.
ā¢ Detail-oriented with strong analytical and problem-solving skills.
ā¢ Experience with safety databases and pharmacovigilance systems.
ā¢ Experience in oncology or rare diseases is a plus.
ā¢ Previous experience interacting with health authorities during inspections and audits.
Company Overview
ā¢ 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 is http://www.eikontx.com.
Company H1B Sponsorship
ā¢ 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 Now
Apply Now