Pharmacovigilance Specialist

Virtual Company; Los Angeles (CA); Remote; USD 65,000 - 67,000; Full time

Job summary

The Fountain Group is seeking a Pharmacovigilance Specialist in Los Angeles, CA (REMOTE) to support global pharmacovigilance activities. You will handle AE case processing, literature monitoring, PSURs, signal detection, and data review while ensuring regulatory timelines and quality deliverables.

Requirements include a Bachelor’s in Life Sciences or related field; advanced degree preferred. This role focuses on PV compliance, audits, CAPA, and collaboration with internal teams and external

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biology or related healthcare discipline required.
• Advanced degree in Pharmacy, Clinical Research or related field preferred.
• Experience with pharmacovigilance processes and regulatory safety reporting.

Responsibilities

• Process AE case reports, manage follow-ups and ensure timely regulatory reporting.
• Notify regulatory agencies and partners of safety events and respond to requests.
• Review scientific literature for safety information.
• Prepare and manage PSURs.
• Evaluate product safety profiles and signal detection reports.
• Maintain pharmacovigilance documentation and records.
• Perform safety case reconciliation with internal teams and partners.
• Participate in PV audits, inspections, CAPA management.
• Develop and update PV SOPs and procedures.
• Support PV training programs and maintain training docs.
• Review product monographs and support regulatory responses and PV agreements.

Skills

PV Operations

AE Processing

ICSRs

Post‑Marketing Surveillance

Product Safety

PV Database Mgmt

Safety Data Analysis

Literature Surveillance

Regulatory Reporting

PV Compliance

Education

Bachelor’s in Life Sciences/Pharmacy/Biology

Advanced degree preferred

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

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