Pharmacovigilance Operations Manager

Job Description

Job Description

Pharmacovigilance Operations Manager

Pay Rate: $85-$135 per 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: 5–15 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

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