Senior Pharmacovigilance (PV) Clinical Scientist

Senior Pharmacovigilance (PV) Clinical Scientist Department Summary 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. The Opportunity 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.

Who you are (Required)

• You possess a 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).
• You have a minimum of 5-7 years of clinical or pharmacovigilance experience in a biopharma company.
• You have the ability to interpret and operationalize new regulations into company SOPs and procedures.
• You are a highly motivated, proactive, and detail-oriented leader who ensures adherence to international regulatory requirements (FDA, EMA, MHRA, and ICH) and maintains inspection readiness.
• You possess knowledge of data privacy laws (GDPR, HIPAA, CCPA) and PV data-transfer principles.
• You are familiar with pharmacovigilance agreements (PVAs).
• You have writing experience: science/medical writing. Excellent written and verbal communication skills, with experience delivering presentations to leadership.
• You possess computer proficiency and proficiency in safety databases.
• You demonstrate proven leadership, project management, and cross-functional influencing skills, with proven ability to drive change management across multiple functions.

Relocation benefits are not available for this posting. The expected salary range for this position, based on the primary location of California, is $120,800.00 - $198,000.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. Apply tot his job Apply To this Job