Sr. Pharmacovigilance (PV) Clinical Scientist
Job Duties
- Conducts drug safety monitoring and adverse event (AE) case processing, including triage, data entry, assessments, labeling review, follow-up, and quality review in compliance with PV regulations and Genentech/Roche SOPs.
- Ensures quality and regulatory compliance of ICSRs, Health Authority submissions, and safety database data.
- Performs clinical review of cases, trend analysis, error assessment, vendor oversight, and implements corrective actions and process improvements.
- Develops, updates, and assesses SOPs, training materials, and process changes related to safety reporting requirements.
- Trains internal and vendor staff, maintains correspondence processes, and monitors PV compliance.
- Serves as SME and primary contact for safety-related activities, supports audits and inspections, prepares presentations, leads projects, and collaborates with stakeholders and patient safety teams.
Qualifications
- Health Care Background (RN/BSN/MSN, NP, RPh/B, Pharm/PharmD) Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities (Preferred)
- Thorough understanding of FDA safety regulations, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations
- Writing experience; science/medical writing (Required)
- Computer proficiency and Data entry experience (Required)
- Project Management (Required)
Benefits
- Comprehensive healthcare coverage (medical, dental, and vision plans)
- Supplemental coverage (accident insurance, critical illness insurance and hospital indemnity)
- 401(k)-retirement savings
- Life & disability insurance
- Employee Assistance Program
- Legal support
- Pet insurance
- Employee discounts with preferred vendors
Pay
Pay Rate: 50-63/hr
Schedule
Schedule: Monday through Friday (8 AM to 4:30 PM PT)
Type
Type: 6 month contract
About the Role
Pride Health is hiring a Sr PV Clinical Scientist for a client located in South San Francisco, CA! The position is a hybrid role with a 6 month contract.
Requirements
Location: South San Francisco, CA
Skills
Health Care Background (RN/BSN/MSN, NP, RPh/B, Pharm/PharmD) Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities (Preferred)
Thorough understanding of FDA safety regulations, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations
Writing experience; science/medical writing (Required)
Computer proficiency and Data entry experience (Required)
Project Management (Required)
Benefits
- Comprehensive healthcare coverage (medical, dental, and vision plans)
- Supplemental coverage (accident insurance, critical illness insurance and hospital indemnity)
- 401(k)-retirement savings
- Life & disability insurance
- Employee Assistance Program
- Legal support
- Pet insurance
- Employee discounts with preferred vendors
Pay
Pay Rate: 50-63/hr
Schedule
Schedule: Monday through Friday (8 AM to 4:30 PM PT)
Type
Type: 6 month contract