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Pharmacovigilance Specialist / Assistant

Kaav Inc.

Job Title: Pharmacovigilance Specialist / Assistant

Location: Remote (Candidates in Fort Worth, TX or Boston, MA preferred for future hybrid)



Job Summary:


seeking a Pharmacovigilance Specialist to support adverse event case processing and safety reporting . This role is highly interactive and requires working closely with patients, healthcare professionals (HCPs), vendors, and internal teams .


The ideal candidate will have strong experience in drug safety, case processing, and regulatory compliance (FDA/Health Canada) , along with the ability to operate in a fast-paced, high-volume environment .

Key Responsibilities:

Adverse Event Case Management (50%)

  • Review and evaluate incoming communications (phone, email, fax, etc.) for adverse event (AE) reporting
  • Perform medical evaluation of AE cases for seriousness and reporting requirements
  • Process and manage cases in safety databases (e.g., ARGUS )
  • Conduct follow-ups to gather missing or additional case information
  • Prepare and submit expedited and periodic safety reports to FDA and Health Canada
  • Ensure AE intake from marketing programs and social media platforms
  • Support audits and regulatory inspections
  • Perform trend analysis and signal detection reporting
Regulatory & Product Knowledge (25%)

  • Maintain knowledge of FDA & Health Canada pharmacovigilance regulations
  • Understand company SOPs, drug safety processes, and compliance requirements
  • Develop knowledge of Galderma products and dermatology-related conditions
Data & Case Tracking (15%)

  • Maintain and update case tracking systems and databases
  • Perform reconciliation with Medical Information, Quality, and external partners
Training & Support (10%)

  • Develop and deliver training on adverse event reporting
  • Support onboarding of new employees and vendors
  • Assist in SOP creation and process documentation
Required Qualifications:

  • Bachelor's degree in Life Sciences, Healthcare, or related field
  • 5+ years of Pharmacovigilance / Drug Safety experience
  • Strong experience in case processing and adverse event reporting
  • Knowledge of FDA and Health Canada safety regulations
  • Hands-on experience with ARGUS or similar safety databases
  • Strong understanding of medical terminology and drug safety concepts
  • Ability to handle patient and HCP interactions (including sensitive discussions)
Preferred Qualifications:

  • RN, PharmD, or other healthcare certification
  • Experience with biologics, drugs, or combination products
  • Background in CROs or Pharma/Biotech companies
  • Experience in SOP writing and training delivery
  • Exposure to global pharmacovigilance environments
Top Skills Required:

  • Pharmacovigilance & Adverse Event Case Processing
  • FDA / Health Canada Regulations
  • ARGUS Safety Database
  • Strong communication with patients & HCPs
  • Critical thinking & escalation judgment
Soft Skills:

  • Self-driven and able to work independently in remote setup
  • Strong communication and collaboration skills
  • Ability to handle high-volume workload and prioritize effectively
  • Comfortable in externally facing, high-visibility role
Nice-to-Have Background:

  • CROs: IQVIA, Parexel, ICON, Syneos, PPD, Labcorp
  • Pharma/Biotech: Pfizer, Amgen, Novartis, AbbVie, Merck
Interview Process:

  • Round 1: Hiring Manager (Nancy Dubois)
  • Round 2: Senior Pharmacovigilance Team
Additional Notes:

  • Immediate need due to high case volume and understaffing
  • Role is highly visible and interactive , not just backend processing
  • Potential for future conversion (must be open to hybrid in TX or MA )
Vacancy posted 2 days ago
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