Sr. Pharmacovigilance (PV) Clinical Scientist

Tailored Management

South San Francisco, CA

JOB DETAILS
SALARY
$41.07–$62.94 Per Hour
SKILLS
Adverse Events, Analysis Skills, Biotech and Pharmaceutical, Case Management, Clinical Assessment, Clinical Medicine, Clinical Research, Communication Skills, Computer Skills, Corrective Action, Cross-Functional, DNA, Data Entry, Dental Insurance, Detail Oriented, Documentation, FDA (Food and Drug Administration), FDA Requirements, Healthcare, ICH Regulations, Identify Issues, International Business, Leadership, Maintain Compliance, Medical and Scientific Writing, Mentoring, Multitasking, Nurse Practitioner, Organizational Skills, Patient Safety, Pharmacovigilance, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Improvement, Project/Program Management, Quality Management, Quality Metrics, Reconciliation, Registered Nurse (RN), Regulations, Regulatory Requirements, Regulatory Submissions, Risk Analysis, Safety Compliance, Safety Process, Safety Standards, Safety/Work Safety, Standard Operating Procedures (SOP), Time Management, Training/Teaching, Training/Teaching Materials, Trend Analysis, USPS (United States Post Office), Vendor/Supplier Evaluation, Vendor/Supplier Selection, Vision Plan, Willing to Travel, Writing Skills
LOCATION
South San Francisco, CA
POSTED
3 days ago
Sr. Pharmacovigilance (PV) Clinical Scientist
Location: 1 DNA Way, South San Francisco, CA 94080
Employment Type: 6-Month Contract (Potential Extension or Full-Time Conversion)
Pay Rate: $41.07 - $62.94/hour (W2)
Benefits: Weekly Pay, Medical, Dental & Vision Insurance
 
Work Schedule
  • Work Model: Hybrid (South San Francisco, CA)
  • Schedule: Monday – Friday
  • Hours: 8:00 AM – 4:30 PM PT
 
Position Overview
We are seeking an experienced Senior Pharmacovigilance (PV) Clinical Scientist to join the US Patient Safety (USPS) Pharmacovigilance Compliance Team. In this role, you will be responsible for the clinical review, evaluation, and processing of adverse event (AE) reports while ensuring compliance with FDA, ICH, EMA, and Roche/Genentech pharmacovigilance standards.
The ideal candidate has extensive experience with Individual Case Safety Reports (ICSRs), adverse event processing, pharmacovigilance compliance, and global safety regulations. This position requires the ability to work independently, lead process improvements, mentor team members, and collaborate across multiple departments to maintain the highest quality standards in patient safety.
 
Key Responsibilities
Pharmacovigilance & Case Management
  • Review, evaluate, and process adverse event (AE) reports in accordance with company SOPs and global regulatory requirements.
  • Perform medical assessment, seriousness, validity, causality, and labeling evaluations for Individual Case Safety Reports (ICSRs).
  • Complete timely and accurate safety case processing using Roche's global safety database.
  • Conduct clinical review of safety cases processed internally and by external vendors.
  • Ensure compliance with FDA, EMA, ICH, and global pharmacovigilance regulations.
Quality & Compliance
  • Lead initiatives to improve the quality of Individual Case Safety Reports (ICSRs).
  • Analyze vendor processing trends, identify quality issues, and recommend corrective actions.
  • Develop executive summaries and quarterly quality trend reports.
  • Ensure Health Authority submissions meet regulatory and company quality standards.
  • Support audits, inspections, and compliance activities.
Process Improvement & Documentation
  • Develop, update, and maintain SOPs, work instructions, and training documentation.
  • Lead process improvement initiatives to enhance pharmacovigilance operations.
  • Perform impact assessments for new regulatory requirements and SOP updates.
  • Implement process changes based on compliance and operational needs.
Training & Collaboration
  • Train and mentor internal teams and external vendors on pharmacovigilance processes and compliance.
  • Serve as a Subject Matter Expert (SME) for safety-related activities within the Global Safety Database.
  • Collaborate with cross-functional teams to support safety data exchange and patient safety initiatives.
  • Act as the primary contact for safety-related activities and support strategic process improvements.
Additional Responsibilities
  • Oversee follow-up activities and correspondence related to adverse event reporting.
  • Ensure product complaints are reported within established timelines.
  • Support adverse event reconciliation and Case Transmission Verification (CTV) activities.
  • Maintain oversight of global pharmacovigilance vendors and identify process risks.
  • Prepare presentations and educational materials for internal and external stakeholders.
  • Support domestic and international business needs as required.
 
Required Qualifications
Education
  • Healthcare Professional degree such as:
    • RN / BSN / MSN
    • Nurse Practitioner (NP)
    • Registered Pharmacist (RPh)
    • B.Pharm / PharmD
    • MD
  • Required
Experience
  • 5–7 years of Pharmacovigilance experience within the biopharmaceutical industry, or
  • Equivalent clinical experience with strong knowledge of:
    • FDA Safety Regulations
    • ICH Guidelines
    • EMA Regulations
    • Global Pharmacovigilance requirements
  • Strong experience with Individual Case Safety Reports (ICSRs).
  • Medical or scientific writing experience.
  • Computer proficiency and data entry experience.
  • Project management experience.
 
Preferred Skills
  • Extensive knowledge of pharmacovigilance operations and safety compliance.
  • Strong understanding of adverse event case processing and medical assessment.
  • Experience working with global safety databases.
  • Excellent analytical, organizational, and problem-solving skills.
  • Strong written and verbal communication skills.
  • Ability to work independently with minimal supervision.
  • Leadership experience, including mentoring and training team members.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Exceptional attention to detail and commitment to quality.
  • Willingness to travel domestically and internationally, as business needs require.
#TMRD

About the Company

T

Tailored Management

CONNECTING TOP TALENT WITH TOP-TIER OPPORTUNITIES

Tailored Management is a global staffing firm that specializes in partnering with large organizations that run their contingent labor program in a VMS/MSP environment. We have the unique capacity to support programs across all scopes and geographic locations from a single headquarters, successfully elevating program performance across the board and minimizing costs, miscommunication and delivery times. But what do we really do? We bring together the best talent with the greatest opportunities.

COMPANY SIZE
1,000 to 1,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1968
WEBSITE
https://www.tailoredmanagement.com/