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/external stakeholders and cross-functional coordination within a global PV framework. This position could be based on site, in South San Francisco, or fully remote. Travel required. All 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 variety of skills typically gained through years of professional experience. Works autonomously with minimal supervision. May lead or contribute skills to projects. May act as a coach for colleagues with less experience and provide guidance. You perform oversight activities to ensure timely and accurate drug safety monitoring, including Adverse Event (AE) triage, evaluation, prompt entry into the global safety database, medical assessment (seriousness/validity/causality/labeling), and ensuring the compliance and quality of all ICSRs and PV-related activities. You ensure global or local PV agreements (PVA) and SOPs align with local regulatory requirements. You lead efforts to update/create SOPs, drive process improvement initiatives, and are responsible for training internal and vendor staff to ensure PV compliance. You ensure the quality of Health Authority (HA) submissions and maintain thorough knowledge of ICSR requirements and relevant pharmacovigilance (PV) regulations and SOPs. You assist or co-lead internal and external audit preparation and mock inspections. You oversee safety-related activities performed by external vendors and internal teams.

Responsibilities

• managing U.S.-specific pharmacovigilance obligations
• ensuring ongoing inspection readiness, regulatory adherence, and effective coordination with internal/external stakeholders
• contributing in-depth knowledge of Individual Case Safety Reports (ICSRs) case processing
• performing oversight activities to ensure timely and accurate drug safety monitoring, including Adverse Event (AE) triage, evaluation, prompt entry into the global safety database, medical assessment (seriousness/validity/causality/labeling), and ensuring the compliance and quality of all ICSRs and PV-related activities
• ensuring global or local PV agreements (PVA) and SOPs align with local regulatory requirements
• leading efforts to update/create SOPs, drive process improvement initiatives, and are responsible for training internal and vendor staff to ensure PV compliance
• ensuring the quality of Health Authority (HA) submissions and maintain thorough knowledge of ICSR requirements and relevant pharmacovigilance (PV) regulations and SOPs
• assisting or co-leading internal and external audit preparation and mock inspections
• overseeing safety-related activities performed by external vendors and internal teams

Requirements

• Health Care Professional degree (e.g., Registered Nurse / Bachelor of Science in Nursing / Master of Science in Nursing, Nurse Practitioner, Registered Pharmacist / Bachelor of Science in Pharmacy, Pharm/Pharm D, or Doctor of Medicine, or closely related 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 detail-oriented leader who ensures adherence to international regulatory requirements (FDA, EMA, MHRA, and ICH) and maintains inspection readiness.
• knowledge of data privacy 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 drive change management across multiple functions.

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