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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Lifecycle Safety, including Pharmacovigilance and Risk Management, while effectively managing project finances, budgets, and customer communications. Proven ability to lead cross-functional teams and deliver tailored solutions in compliance with regulatory requirements.
Highest-signal resume keywords
Lifecycle Safety ManagementProject Management ExperienceGood Clinical Practice (GCP)Financial Analysis and BudgetingEffective Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Lifecycle SafetyPharmacovigilanceRisk ManagementProject Financial ManagementBudget CreationRegulatory ComplianceClinical Research GuidelinesProposal DevelopmentAudit SupportChange Order Management
Soft Skills
Prioritization SkillsOrganizational SkillsNegotiating SkillsProblem-Solving SkillsConflict Resolution Skills
Certifications & Qualifications
Life Sciences Degree
Industry Keywords
Good Clinical Practice (GCP)International Conference on Harmonization (ICH)IQVIA Standard Operating ProceduresClinical ResearchSafety Subject Matter Expert
About the role
Key responsibilities & impact- Manage customer interface and communication for assigned projects and serve as the primary Lifecycle Safety point of contact
- Manage customer deliverables, project planning, scope, quality and project financial management
- Act as an account owner over programs or customer portfolios and report program or portfolio metrics
- Craft and defend proposed solutions for new standalone Safety business opportunities
- Formulate operational budgetary assumptions and steer budget creation and pricing strategy
- Provide Safety Subject Matter Expert leadership for customer-facing collateral, presentations and meetings
- Lead customer service interface from scoping and proposal generation through bid defense, transition and service delivery
- Manage project finances, financial systems, revenue recognition, invoicing, budgets, financial analysis and change orders
- Develop specialist expertise and support departmental or global initiatives as a Subject Matter Expert
- Support new project start-up, identify risks and implement mitigation measures
- Attend internal and external stakeholder meetings, provide project status updates and define processes and strategy
- Work with Sales and Proposals on tailored opportunity responses and business growth
- Participate in sales activities, sales presentations, bid defenses and proposal development
- Contribute to client and internal audits and inspections and support Corrective Action Plans
- Work with Lifecycle Safety management to address problem areas and customer needs
- Perform other duties as assigned
Requirements
What you’ll need- Life Sciences Degree or other directly related field
- Minimum 3 years' experience in Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience
- Knowledge of applicable global, regional and local clinical research regulatory requirements, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and IQVIA Standard Operating Procedures
- Strong prioritization, planning and organizational skills
- Effective verbal and written communication skills, including ability to work and lead teleconferences
- Effective collaborative, organizational and delegation skills
- Ability to independently work on multiple projects and manage competing priorities
- Strong presentation, report writing and customer focus skills
- Accountability, ownership and transparency
- Independent judgment, negotiating, decision-making, and problem-solving skills
- Business acumen and financial analytical skills, tactical planning, and budgeting
- Creative, innovative, initiative and proactive approach
- Effective motivating, influencing and conflict resolution skills
- Ability to establish and maintain effective working relationships with coworkers, managers and customers
