Pharmacovigilance Specialist-Nursing
Job Summary: The company is seeking an experienced Clinical Pharmacovigilance Vendor Oversight Specialist to support post-marketing safety operations and ensure compliant processing of adverse event reports by external vendor partners. This role is responsible for quality oversight of Individual Case Safety Reports (ICSRs), vendor performance monitoring, training support, audit readiness, and collaboration with cross-functional safety teams. The ideal candidate will bring a combination of clinical healthcare experience and pharmacovigilance expertise in a regulated environment. Key Responsibilities:
- Conduct oversight of external vendors responsible for post-marketing adverse event case processing
- Review and assess safety cases to ensure compliance with global pharmacovigilance regulations and internal standards
- Evaluate case quality, identify processing errors, and provide corrective feedback to vendor teams
- Ensure accurate assessment of seriousness, causality, labeling, and follow-up requirements for adverse event reports
- Respond to vendor inquiries related to case processing and safety reporting requirements
- Monitor safety operations mailboxes, escalations, and quality-related issues
- Support vendor performance management through quality reviews and process monitoring
- Participate in audits, inspections, and regulatory readiness activities
- Develop and deliver training, retraining, and knowledge-sharing sessions for vendor personnel
- Collaborate with Quality, Compliance, Safety Operations, and other cross-functional stakeholders
- Contribute to departmental projects, process improvements, and operational excellence initiatives
Required Qualifications:
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline
- Registered Nurse, Bachelor of Science in Nursing, Doctor of Pharmacy, Medical Doctor, or equivalent healthcare background preferred
- Minimum 5 years of combined clinical and pharmacovigilance experience
- Experience in post-marketing pharmacovigilance and adverse event management
- Hands-on experience with Individual Case Safety Report processing and review
- Strong understanding of global pharmacovigilance regulations and guidelines
- Knowledge of seriousness assessment, causality assessment, labeling review, and follow-up activities
- Experience conducting quality reviews and oversight of safety case processing activities
- Excellent verbal and written communication skills
- Ability to work independently in a remote environment while collaborating across multiple teams
Preferred Qualifications:
- Clinical experience in Emergency Room, Intensive Care Unit, Critical Care, Cardiac Care, or Coronary Care settings
- Vendor oversight or vendor management experience within pharmacovigilance operations
- Audit and inspection support experience
- Experience delivering training and retraining programs
- Knowledge of safety databases and pharmacovigilance technologies
- Experience supporting large global vendor organizations
- Experience with process improvement initiatives and project-based work
- Experience using safety management systems and databases
Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable. Pay Range: $30/hr to $38/hr