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Manager, Pharmacovigilance
AssistRxManager, Pharmacovigilance leading compliance activities and operational support for drug safety. Collaborating with Quality Assurance and cross-functional teams to uphold safety standards.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in pharmacovigilance and compliance, with a strong focus on regulatory requirements and quality assurance. Capable of leading cross-functional teams and driving continuous improvement initiatives in PV operations.
Highest-signal resume keywords
Pharmacovigilance ComplianceGlobal PV RegulationsHealth Authority InspectionsQuality Reporting ToolsStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacovigilanceDrug SafetyRegulatory ComplianceQuality AssuranceRisk ManagementProcedural Document DevelopmentSafety Signal DetectionPerformance MetricsAudit ReadinessRegulatory Filings
Soft Skills
LeadershipCollaborationProblem-SolvingOrganizational SkillsCommunication Skills
Tools & Technologies
PV DatabasesQuality Reporting ToolsTraining Programs
Certifications & Qualifications
Certification in PharmacovigilanceCompliance Certification
Industry Keywords
BiopharmaceuticalBiotechnologyICH GuidelinesGVP ModulesDEAState Board of PharmacyURACACHCOIG
About the role
Key responsibilities & impact- Lead frontline operational support for pharmacovigilance (PV) activities
- Drive the execution of PV compliance activities to meet global regulatory requirements
- Partner closely with Quality Assurance and Operations to develop, implement, and manage PV compliance frameworks
- Work directly with cross-functional teams to facilitate an integrated approach to PV compliance
- Ensure PV systems are audit-ready, including preparing for regulatory authority inspections
- Conduct regular assessments of PV risk management and address compliance gaps
- Monitor regulatory changes in PV and assess their impact on front-end operations
- Oversee and assess quality performance of internal and external resources
- Support internal and external PV audits
- Contribute to the development and delivery of PV compliance training
- Facilitate the timely preparation and submission of regulatory filings
- Assist in investigations of compliance breaches
- Engage in continuous improvement initiatives
- Perform other related duties as assigned
- Carry out supervisory responsibilities in accordance with the organization's policies
Requirements
What you’ll need- Education: Bachelor’s degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience required.
- 7+ years of experience in pharmacovigilance/drug safety, with 3+ years in a compliance, oversight, or quality-driven role.
- Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules.
- Experience with health authority inspections (e.g., DEA, State Board of Pharmacy, URAC and ACHC, OIG, etc.) and audit readiness.
- Experience in biopharmaceutical or biotechnology industries preferred
- Certification in pharmacovigilance, compliance, or related fields preferred
- Familiarity with PV databases and safety signal detection tools preferred
- Experience working with cross-functional teams, including patient-facing teams, with proven skills in stakeholder management.
- Proficiency in quality reporting tools and establishing performance metrics.
- Experience drafting and developing procedural documents and training programs.
- Strong organizational and leadership skills with a focus on front-end and patient-centered operations.
- Excellent collaboration and engagement skills, with the ability to drive cross-functional teamwork.
- Proven project management and problem-solving abilities.
- Detail-oriented, analytical, and capable of managing complex requirements in a fast-paced environment.
- Strong written and verbal communication skills.
Benefits
Comp & perks- Supportive, progressive, fast-paced environment
- Competitive pay structure
- Matching 401(k) with immediate vesting
- Medical, dental, vision, life, & short-term disability insurance
- #TransformingLives Honor
- Values Award
- Vision Award