Sr. Pharmacovigilance Clinical Scientist

Our client, a world
leader in biotechnology and gene therapy, is looking for an “Sr.
Pharmacovigilance Clinical Scientist” based in South San Francisco, CA (Hybrid).

Job Duration: Long
Term Contract (Possibility Of Extension)

Pay Rate : $65/hr on W2

Company Benefits: Medical, Dental,
Vision, Paid Sick leave, 401K

The Sr. PV Clinical
Scientist supports US Patient Safety by providing expert clinical review,
evaluation, and quality oversight of Individual Case Safety Reports (ICSRs) and adverse event (AE) information. This role ensures case processing,
follow-up, labeling assessments, and Health Authority submissions comply with
company SOPs, PV regulations, and applicable global requirements.

The position works
autonomously as a subject matter expert, supports vendor oversight, drives
quality and process improvements, and may lead projects and train internal and
external teams.

Key Responsibilities

• Conduct
  clinical review and quality assessment of AE/ICSR cases processed
  internally or by vendors.
  
• Evaluate
  case validity, seriousness, causality, labeling, and follow-up
  requirements.
  
• Ensure
  accurate and timely case processing in the global safety database.
  
• Monitor
  case quality, error trends, vendor performance, and potential compliance
  risks.
  
• Support
  PV compliance with FDA, ICH, EMA, GVP, and applicable global regulations.
  
• Lead
  process improvements, SOP updates, training initiatives, and quality trend
  reporting.
  
• Support
  vendor oversight, audits, inspections, reconciliations, and case
  transmission verification.
  
• Oversee
  follow-up activities, correspondence, and data corrections.
  
• Support
  technical and medical product complaint reporting and escalation.
  
• Collaborate
  with cross-functional teams and serve as a subject matter expert for
  safety-related activities.
  
• Prepare
  presentations, executive summaries, and scientific/medical documentation.
  

Required Qualifications

• Healthcare
  professional degree such as RN/BSN/MSN, PharmD, RPh/BPharm, NP, MD,
  or related qualification.
  
• 5–7+
  years of pharmacovigilance experience in a biopharmaceutical environment or equivalent
  clinical experience with strong knowledge of safety regulations.
  
• Strong
  experience with ICSR case processing and clinical review.
  
• Knowledge
  of FDA, ICH, EMA, GVP, and global pharmacovigilance regulations.
  
• Experience
  with medical/scientific writing, data entry, and project management.
  
• Strong
  analytical, communication, organizational, and problem-solving skills.
  
• Ability
  to work independently, manage complex issues, and collaborate effectively
  with internal teams and external vendors.
  

If interested, please
send us your updated resume at

[email protected]/[email protected]