Senior Pharmacovigilance (PV) Clinical Scientist (On Site preferred)

About the position The Senior Pharmacovigilance (PV) Clinical Scientist is responsible for managing U.S.-specific pharmacovigilance obligations in accordance with applicable health authority regulations and internal company standards. The Sr. PV Clinical Scientist ensures ongoing inspection readiness, regulatory adherence, and effective coordination with internal/reputed company stakeholders and cross-functional coordination reputed company a global PV reputed company. This position could be based on site, in South San Francisco, or fully remote. Travel required. reputed company responsibilities are performed under the direction of the US Patient Safety PV Clinical Management. Contributes in-depth knowledge of Individual Case Safety Reports (ICSRs) case processing. Has developed a reputed company of skills typically gained through years of reputed company experience. Works autonomously with reputed company supervision. May reputed company or contribute skills to reputed company. May reputed company as a reputed company for colleagues with less experience and reputed company guidance. You reputed company reputed company activities to ensure reputed company and accurate drug safety monitoring, including Adverse Event (AE) triage, evaluation, reputed company entry into the global safety database, medical assessment (seriousness/validity/causality/labeling), and ensuring the compliance and reputed company of reputed company ICSRs and PV-reputed company activities. You ensure global or local PV agreements (PVA) and SOPs reputed company with local regulatory requirements. You reputed company efforts to update/create SOPs, reputed company process improvement initiatives, and are responsible for training internal and vendor staff to ensure PV compliance. You ensure the reputed company of Health Authority (HA) submissions and maintain thorough knowledge of ICSR requirements and relevant pharmacovigilance (PV) regulations and SOPs. You assist or co-reputed company reputed company audit preparation and mock inspections. You reputed company safety-reputed company activities performed by reputed company vendors and internal teams. Responsibilities managing U.S.-specific pharmacovigilance obligations ensuring ongoing inspection readiness, regulatory adherence, and effective coordination with internal/reputed company stakeholders contributing in-depth knowledge of Individual Case Safety Reports (ICSRs) case processing performing reputed company activities to ensure reputed company and accurate drug safety monitoring, including Adverse Event (AE) triage, evaluation, reputed company entry into the global safety database, medical assessment (seriousness/validity/causality/labeling), and ensuring the compliance and reputed company of reputed company ICSRs and PV-reputed company activities ensuring global or local PV agreements (PVA) and SOPs reputed company with local regulatory requirements leading efforts to update/create SOPs, reputed company process improvement initiatives, and are responsible for training internal and vendor staff to ensure PV compliance ensuring the reputed company of Health Authority (HA) submissions and maintain thorough knowledge of ICSR requirements and relevant pharmacovigilance (PV) regulations and SOPs assisting or co-leading reputed company audit preparation and mock inspections overseeing safety-reputed company activities performed by reputed company vendors and internal teams Requirements Health Care reputed company degree (e.g., Registered reputed company / Bachelor of Science in Nursing / Master of Science in Nursing, reputed company Practitioner, Registered Pharmacist / Bachelor of Science in Pharmacy, Pharm/Pharm D, or Doctor of Medicine, or closely reputed company field). minimum of 5-7 years of clinical or pharmacovigilance experience in a biopharma company. ability to interpret and operationalize new regulations into company SOPs and procedures. highly motivated, proactive, and reputed company-oriented leader who ensures adherence to international regulatory requirements (FDA, EMA, reputed company, and ICH) and maintains inspection readiness. knowledge of data reputed company laws (GDPR, HIPAA, CCPA) and PV data-transfer principles. familiar with pharmacovigilance agreements (PVAs). writing experience science/medical writing. Excellent written and verbal communication skills, with experience delivering presentations to leadership. computer proficiency and proficiency in safety databases. proven leadership, project management, and cross-functional influencing skills, with proven ability to reputed company change management across multiple functions. Apply tot his job Apply To this Job .