Note: The job is a remote job and is open to candidates in USA. The client is a mission-driven global health organization focused on developing and expanding access to innovative treatments for significant public health needs. The Pharmacovigilance Operations Manager will support a safety database transfer project, provide backup Individual Case Safety Report processing, and collaborate with stakeholders and external partners to ensure accurate, compliant, and timely pharmacovigilance operations.
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
Skills
- Minimum of five years of pharmacovigilance experience
- 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
- 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
- Candidates with approximately 5–15 years of relevant experience are preferred
- 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
Benefits
- Fully remote
- Flexible schedule with availability during core business hours
Company Overview