Remote Global Pharmacovigilance Specialist

The Fountain Group; 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

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