Pharmacovigilance Operations Manager

Kelly Services-Portugal; New York (NY); Remote; USD 103,000 - 124,000; Part time

Job summary

Mykelly is seeking a Pharmacovigilance Operations Manager for a remote, part-time six-month contract in the United States. The role focuses on a safety database transfer, Argus Safety, ICSR processing, and ICH E2B(R3), with about 20 hours per week.

You will work independently in a remote environment, collaborating with internal teams, CROs, vendors, and project partners to ensure accurate, compliant pharmacovigilance operations in a timely manner.

Qualifications

• Five+ years in pharmacovigilance
• Hands-on safety database setup, transfer, or migration
• Strong experience with Argus Safety
• Experience processing Individual Case Safety Reports (ICSRs)
• Familiarity with ICH E2B(R3) reporting standards

Responsibilities

• Plan and execute pharmacovigilance safety database transfers or migrations
• Assist with database setup, mapping, transfer, reconciliation, validation, and quality checks
• Provide backup for ICSR intake and case processing
• Maintain accurate safety case information in Argus Safety
• Support electronic safety reporting and ICH E2B(R3) requirements
• Identify and help resolve data discrepancies and transfer issues
• Collaborate with internal teams, CROs, vendors, and project partners

Skills

Pharmacovigilance

Argus Safety

ICSR processing

ICH E2B(R3)

Data mapping

Job description

Pharmacovigilance Operations Manager

Pay Rate: $75-$90per hour

Employment Type: Temporary contract

Contract Length: Six months, with potential for extension

Schedule: Part-time, approximately 20 hours per week

Work Arrangement: Fully remote

Availability: Flexible schedule with availability during core business hours

Experience Required: 5 or more direct years of pharmacovigilance experience

About the Opportunity

Our client is a mission-driven global health organization focused on developing and expanding access to innovative treatments for significant public health needs. The organization collaborates with pharmaceutical companies, research institutions, government agencies, nonprofit partners, and international health organizations to support the development and availability of life-saving therapies.

Position Overview

The Pharmacovigilance Operations Manager will support a safety database transfer project while providing backup support for Individual Case Safety Report processing. This role is ideal for an experienced pharmacovigilance professional with hands-on experience in safety database migration, Argus Safety, ICSR processing, and ICH E2B(R3).

The successful candidate will work independently in a remote environment and collaborate with internal stakeholders, vendors, and project partners to support accurate, compliant, and timely pharmacovigilance operations.

Key Responsibilities

• Support the planning and execution of a pharmacovigilance safety database transfer or migration.
  
• Assist with database setup, data mapping, transfer, reconciliation, validation, and quality checks.
  
• Provide backup support for ICSR intake and case processing.
  
• Review and maintain accurate safety case information in the Argus Safety database.
  
• Support case follow-up, duplicate checks, medical coding, and case documentation as needed.
  
• Assist with electronic safety reporting and ICH E2B(R3) requirements.
  
• Identify and help resolve data discrepancies, validation errors, and transfer-related issues.
  
• Maintain accurate project records and documentation in accordance with company procedures and regulatory requirements.
  
• Collaborate with internal teams, CROs, vendors, and external project partners.
  
• Track project progress and communicate risks, delays, or quality concerns.
  
• Support additional pharmacovigilance operations activities as assigned.

Required Qualifications

• Minimum of five years of pharmacovigilance experience; candidates with approximately 5–15 years of relevant experience are preferred.
  
• Hands-on experience supporting safety database setup, transfer, or migration projects.
  
• Strong experience with Argus Safety.
  
• Experience processing Individual Case Safety Reports (ICSRs).
  
• Familiarity with ICH E2B(R3) electronic safety reporting standards.
  
• Experience with data mapping, reconciliation, validation, or quality control preferred.
  
• Strong knowledge of pharmacovigilance processes, documentation, and regulatory expectations.
  
• Excellent attention to detail, organization, and problem-solving skills.
  
• Ability to work independently and manage priorities in a remote environment.
  
• Strong written and verbal communication skills.
  
• Availability to work approximately 20 hours per week during mutually agreed-upon core business hours.

Preferred Qualifications

• Experience working with pharmaceutical, biotechnology, clinical research, or nonprofit drug-development organizations.
  
• Experience collaborating with CROs, vendors, or external safety partners.
  
• Familiarity with safety database testing, workflow configuration, or implementation activities.
  
• Experience with audit readiness, SOPs, quality systems, or regulatory reporting requirements.