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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance with a strong focus on client relationship management, operational governance, and regulatory compliance. Proven ability to lead cross-functional teams and drive service delivery excellence while ensuring adherence to industry standards.
Highest-signal resume keywords
Pharmacovigilance ExperienceClient-Facing Project LeadershipKnowledge of FDA, EMA, ICH RegulationsPMP CertificationExperience with Project Management Tools
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Case ProcessingAggregate ReportingLiterature SurveillanceSignal ManagementRegulatory SubmissionsSafety Management PlansKPI MonitoringQuality MetricsBudget PerformanceOperational Excellence
Soft Skills
Excellent CommunicationStakeholder ManagementPresentation SkillsRelationship BuildingProblem Solving
Tools & Technologies
Project Management Tools
Certifications & Qualifications
PMP Certification
Industry Keywords
PharmacovigilanceCRO ExperiencePharmaceutical ClientsBiotechnology ClientsDiversity, Equity, and Inclusion
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Serve as the primary client-facing pharmacovigilance director for assigned client programs
- Provide strategic oversight, operational governance, and delivery excellence
- Serve as the primary point of contact for assigned clients and build trusted relationships
- Plan, track, and drive delivery of milestones, risks, dependencies, and action items
- Lead governance meetings, operational reviews, status meetings, client communications, and executive reviews
- Identify, manage, and resolve client concerns, risks, and escalations
- Coordinate cross-functional teams for alignment, accountability, and timely execution
- Oversee case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions
- Develop and maintain Safety Management Plans
- Monitor KPIs, quality metrics, and client feedback to drive service delivery excellence
- Ensure compliance with FDA, EMA, ICH, and client-specific requirements
- Support audits, inspections, CAPA management, and regulatory inquiries
- Monitor billing, invoicing, resource utilization, and budget performance
- Demonstrate commitment to diversity, equity, and inclusion
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline
- 10+ years of pharmacovigilance experience
- 5+ years of client-facing project leadership experience
- Strong knowledge of FDA, EMA, ICH, and global PV regulations
- Experience supporting inspections and audits
- Experience overseeing end-to-end pharmacovigilance services
- Excellent communication, stakeholder management, and presentation skills
- Ability to manage multiple complex client programs and priorities
- Less than 15% travel
- 40–45 hours per week
- Advanced degree in Life Sciences, Pharmacy, Nursing, or related discipline preferred
- CRO or pharmacovigilance services experience preferred
- Experience managing pharmaceutical and biotechnology clients preferred
- PMP certification preferred
- Experience with project management tools preferred
- Demonstrated record of client satisfaction and operational excellence preferred
Benefits
Comp & perks- Competitive salaries and benefits
- Remote work option
- Equal Opportunity Employer
- Reasonable accommodation during the hiring process for qualified applicants with disabilities
