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 )

Apply

Vacancy posted 2 days ago

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