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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance and risk management processes, with a strong focus on regulatory compliance and stakeholder engagement. Proven ability to develop and implement effective training and communication strategies while monitoring process performance and continuous improvement.
Highest-signal resume keywords
PharmacovigilanceRisk ManagementRegulatory Compliance AuditsProcess GovernanceStakeholder 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
PharmacovigilanceRisk ManagementSafety DatabasesRegulatory ComplianceProcess Performance MonitoringTraining DevelopmentMetrics InterpretationAdverse Event ReportingClinical JudgmentGlobal Program Development
Soft Skills
Strong Written CommunicationVerbal CommunicationFacilitation SkillsConsultative SkillsCross-Functional Teamwork
Tools & Technologies
SOP DevelopmentCompliance Monitoring ToolsRisk Evaluation and Mitigation Strategies
Industry Keywords
CSRM ProcessesQPPV OversightPASSPSMPARMMPSMFHealth Authority Interactions
About the role
Key responsibilities & impact- Own assigned CSRM processes end to end
- Oversee development and maintenance of departmental SOPs and execution resources
- Ensure cross-functional and cross-divisional stakeholder engagement
- Evaluate emerging regulations and integrate necessary changes into processes
- Coordinate with SOP owners and stakeholders to maintain compliant end-to-end processes
- Monitor process performance, metrics, compliance, and continuous improvement opportunities
- Serve as the primary contact for assigned processes with internal and external stakeholders and governance committees
- Develop and implement mitigation plans for process risks
- Provide expert consultation on pharmacovigilance, risk management, health authority interactions, and process interpretation
- Educate and mentor stakeholders on pharmacovigilance, risk management, and process responsibilities
- Oversee communications regarding process changes and emerging issues
- Identify training needs and support training development and delivery
- Lead engagement with auditors, inspectors, and regulators
- Develop and evaluate pharmacovigilance activities, Risk Management Plans, Risk Evaluation and Mitigation Strategies, and risk minimization strategies
- Develop regulatory document strategies and prepare responses to safety inquiries
- Support local regulatory consideration assessments and alignment with global processes
- Coordinate PASS, PSMP, and ARMM process requirements and stakeholder communication
- Partner with the QPPV office on escalation, oversight, and accurate PSMF content
Requirements
What you’ll need- Master's degree in nursing, PharmD, PA, or another relevant clinical health-related field preferred
- Clinically relevant medical experience in the undergraduate or graduate program
- 10–12 years of professional experience with both clinical and pharmaceutical industry experience required
- Minimum of 5 years of safety experience, such as pharmacovigilance or clinical experience, involving direct participation in varied pharmacovigilance processes
- Expertise in pharmacovigilance and risk management processes
- Ability to translate complex regulatory and procedural requirements into practical, product-specific guidance
- Strong written and verbal communication, facilitation, consultative, and stakeholder-management skills
- Ability to influence without direct authority and resolve complex cross-functional issues
- Experience in process governance, compliance monitoring, metrics interpretation, continuous improvement, and training development and delivery
- Ability to partner with CSRM teams, IPV, regulatory stakeholders, and the QPPV office
- Knowledge of PASS, PSMPs, ARMMs, QPPV oversight, and the PSMF
- Direct experience in PASS, PSMPs, ARMMs, QPPV oversight, and/or PSMF preferred
- Adverse Event Report
- Clinical Judgment
- Cross-Functional Teamwork
- Detail-Oriented
- Drug Safety Surveillance
- Global Program Development
- Pharmacovigilance
- Regulatory Compliance Audits
- Risk Management
- Safety Databases
- US and Puerto Rico residents only
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Accommodation support during the application or hiring process