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.
  
• 57 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

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