Job Description
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 )
Job Tags
Immediate start, Remote work