Pharmacovigilance Specialist

Connexion Systems + Engineering; Emeryville (CA); Hybrid; USD 65,000 - 69,000; Full time

Benefits offered by this job

100% Remote

Global team collaboration

Competitive pay

Job summary

Connexion Systems & Engineering Inc. in the United States is seeking experienced Pharmacovigilance Specialists for a fully remote role (PST hours) on a 1+ year contract. Work with a global team to process adverse event reports, maintain safety data, and ensure regulatory compliance. Two openings, competitive hourly rate.

Qualifications

• Professional experience in pharmacovigilance or adverse event case management.
• Hands-on experience processing and documenting AE reports.
• Experience using a pharmacovigilance safety database.
• Understanding global pharmacovigilance regulations and compliance standards.

Responsibilities

• Process, review, and triage adverse event reports for marketed products.
• Conduct follow-up communications with patients and healthcare professionals to obtain safety information.
• Maintain accurate case documentation in pharmacovigilance databases.
• Ensure compliance with global reporting requirements and submission timelines.
• Review literature to identify potential adverse events and emerging safety concerns.
• Support PSURs and safety reporting activities.

Skills

Adverse event reporting

Pharmacovigilance

AE case processing

Independent work

Tools

Argus Safety

Job description

Title: Pharmacovigilance Specialists Hiring Organization: Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration: 1+ year contract Pay rate: $47 - $50/hr Job Location: West Coast, USA Work Model: 100% Remote (PST working hours) Schedule: Monday - Friday, full-time (must be able to accommodate global meetings) Openings: 2 Job#: bh19818

Description

We are seeking experienced Pharmacovigilance Specialists to support global drug safety operations for an established biopharmaceutical organization. This remote opportunity focuses on adverse event case processing, post-marketing safety surveillance, and global regulatory compliance. The ideal candidate will have hands-on experience managing adverse event reports, working with pharmacovigilance safety databases, and ensuring accurate, timely reporting in accordance with international regulatory requirements. This position supports a global team, so flexibility to accommodate occasional meetings across international time zones is important.

Key Responsibilities

• Process, review, and triage adverse event (AE) and drug safety case reports for marketed pharmaceutical products.
• Conduct follow-up communications with patients, healthcare professionals, and other adverse event reporters to obtain additional safety information.
• Maintain accurate case documentation and safety data within pharmacovigilance databases.
• Ensure compliance with global pharmacovigilance regulations, reporting requirements, and submission timelines.
• Review scientific literature and other safety information to identify potential adverse events and emerging safety concerns.
• Support periodic safety reporting, including Periodic Safety Update Reports (PSURs).
• Participate in safety case reconciliation, signal detection activities, and ongoing product safety evaluations.
• Assist with pharmacovigilance audits, inspections, corrective and preventive actions (CAPAs), and regulatory inquiries.
• Maintain documentation and support updates to Standard Operating Procedures (SOPs) and pharmacovigilance processes.
• Collaborate with cross-functional and international teams to ensure accurate and timely safety reporting.

Qualifications

• Professional experience in pharmacovigilance, drug safety, or adverse event case management.
• Hands-on experience processing, reviewing, and documenting adverse event reports.
• Experience using a pharmacovigilance safety database.
• Understanding of global pharmacovigilance regulations, adverse event reporting requirements, and compliance standards.
• Experience conducting adverse event follow-ups and evaluating safety-case information.
• Strong analytical, organizational, and documentation skills.
• Ability to work independently in a remote environment while collaborating with international teams.

Preferred

• Oracle Argus Safety database experience is strongly preferred.
• Experience supporting post-marketing pharmacovigilance activities.
• Familiarity with FDA, EMA, and ICH pharmacovigilance guidelines.
• Experience preparing or contributing to PSURs or other aggregate safety reports.
• Experience with safety signal detection, scientific literature review, or case reconciliation.
• Familiarity with pharmacovigilance quality systems, SOPs, audits, and CAPAs.

Why Consider This Opportunity?

• 100% Remote: Work remotely while collaborating with an international drug safety team.
• Global Exposure: Support pharmacovigilance operations involving marketed pharmaceutical products and international regulatory requirements.
• Meaningful Work: Contribute to patient safety through adverse event monitoring, accurate reporting, and ongoing product safety surveillance.
• Competitive Compensation: $47.00-50.00 per hour.