Pharmacovigilance Specialist
Company: The Fountain Group Agency
- Location: Los Angeles, United States
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
Job Title: Pharmacovigilance Specialist
Location: Los Angeles, CA (REMOTE)
Pay Rate: $47.50-$48.50/hr.
Duration: 12 Months
Job Description
Provides operational support for global pharmacovigilance activities involving marketed pharmaceutical products. Ensures compliance with global regulatory reporting requirements and timelines while maintaining the quality of pharmacovigilance deliverables. Responsible for adverse event case processing, safety data review, analysis, scientific literature monitoring, and maintenance of integrated safety databases.
Key Responsibilities:
- Process adverse event (AE) case reports, manage follow-ups, and ensure timely regulatory reporting.
- Notify regulatory agencies and business partners of safety events and respond to pharmacovigilance-related regulatory requests.
- Review scientific literature and bibliographic sources for safety information.
- Prepare and manage Periodic Safety Update Reports (PSURs).
- Evaluate product safety profiles and prepare signal detection reports.
- Maintain pharmacovigilance documentation, filing, and archiving records.
- Perform safety case reconciliation with internal departments, affiliates, distributors, and business partners.
- Participate in pharmacovigilance audits, inspections, self-inspections, and CAPA management.
- Develop and update pharmacovigilance SOPs, procedures, and working instructions.
- Support pharmacovigilance training programs and maintain training documentation.
- Review product monographs and support regulatory responses, pharmacovigilance agreements, and contracts.
Education
- Bachelor's degree in Life Sciences, Pharmacy, Biology, or a related healthcare discipline required.
- Advanced degree in Pharmacy, Clinical Research, Medicine, or a related healthcare field preferred.
Required Skills
- Global Pharmacovigilance Operations
- Adverse Event (AE) Case Processing
- Individual Case Safety Reports (ICSRs)
- Post-Marketing Safety Surveillance
- Marketed Pharmaceutical Product Safety
- Pharmacovigilance Database Management
- Safety Data Review and Analysis
- Scientific Literature Surveillance
- Regulatory Safety Reporting
- Pharmacovigilance Compliance
Preferred Skills
- Periodic Safety Update Reports (PSURs)
- Signal Detection and Safety Evaluation
- Pharmacovigilance Audits and Inspections
- CAPA Management
- Case Reconciliation
- Pharmacovigilance SOP Development
- Product Monograph Review
- Pharmacovigilance Agreements and Contracts
- Regulatory Agency Correspondence Pharmacovigilance Training Documentation
