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Crossdomain Solutions

Principal/Senior Principal – Pre-Sales Solution Consulting - Pharmacovigilance Services

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Job Description

About the Role

We are seeking experienced Pre-Sales Solution Consulting Principals to support strategic client engagement and solution development across our Pharmacovigilance (PV) services and technology portfolio. This role sits at the intersection of domain expertise, commercial strategy, and solution architecture, partnering closely with PV Operations, Sales, Delivery, Product, and Client stakeholders to design compelling, scalable, and differentiated client solutions.

The successful candidate will bring a strong understanding of global and local pharmacovigilance operations and regulatory requirements, good commercial judgment, and the ability to translate complex client needs into winning service and technology propositions. They will contribute to and sometimes lead solution strategy and design for large, complex deals and play a critical role in revenue growth, client satisfaction, and market positioning.

Responsibilities

Solution Design & Client Engagement

  • Contribute to and sometimes lead end-to-end solution design for strategic pharmacovigilance services and technology opportunities
  • Partner with Sales to shape client strategy, value propositions, and win themes
  • Translate client requirements into scalable, compliant, and commercially viable solutions
  • Serve as a trusted advisor to client stakeholders across Safety, Regulatory, Quality, and IT functions
  • Contribute to and sometimes lead discovery workshops, solution presentations, and executive briefings

Commercial & Deal Support

  • Lead the content creation for assigned bids, RFPs, and proactive proposals for PV outsourcing and technology-enabled services
  • Support the development and maintenance of pricing strategies, effort models, and commercial constructs aligned to client objectives
  • Balance risk, margin, and competitiveness in solution development
  • Contribute to contract negotiations and solution governance frameworks
  • Support solution standardization and reusability to improve bid efficiency and profitability

Domain & Technology Expertise

Provide subject matter expertise in pharmacovigilance processes, including:

  • Case processing and triage
  • Aggregate reporting (PSUR/PBRER/DSUR)
  • Signal detection and risk management
  • Literature surveillance
  • Safety database operations
  • Regulatory compliance and inspections

Understand and position PV technologies, including:

  • Safety databases
  • Intake tools and the competitive landscape
  • Workflow and automation platforms
  • AI/ML-enabled pharmacovigilance solutions
  • Regulatory reporting and compliance tools
  • Signal Detection & Signal Management tools

Stay current with global pharmacovigilance regulations and industry trends

Capability Development

  • Collaborate with pharmacovigilance and technology SMEs
  • Evolve the best practices for solution design and pre-sales engagement
  • Build reusable solution assets, playbooks, and reference architectures
  • Support capability development across pharmacovigilance services and technology offerings
  • Collaborate with Delivery and Product teams to ensure solution feasibility and scalability

Market & Offering Development

  • Contribute to the development of new service offerings and solution accelerators
  • Identify market trends and client needs to inform product and service strategy
  • Participate in thought leadership and go-to-market initiatives
  • Participate in industry events, client forums, and capability presentations

Required Qualifications & Skills:

Experience

  • 5–10+ years in pharmacovigilance, drug safety, or life sciences services
  • 3+ years in pre-sales, solution consulting, or client solution design
  • Demonstrated experience supporting large pharmacovigilance outsourcing and/or technology transformation deals
  • Experience working with global pharmaceutical or biotech clients
  • Proven track record contributing to revenue growth and successful deal closures

Domain Expertise

  • Good working knowledge of:
  • Global pharmacovigilance regulations (FDA, EMA, MHRA, ICH)
  • End-to-end pharmacovigilance processes, global and local
  • Safety databases and PV technology ecosystems
  • Quality and compliance frameworks
  • Inspection readiness and regulatory audits

Commercial & Leadership Skills

  • Strong business and financial acumen
  • Ability to design commercially viable service and technology solutions
  • Excellent stakeholder management and executive communication skills
  • Ability to lead cross-functional teams in assigned deals
  • Strategic thinking combined with operational pragmatism

Preferred Skills:

  • Experience in pharmacovigilance outsourcing or managed services
  • Experience with digital transformation or automation in PV
  • Familiarity with AI / data / analytics solutions in safety
  • Experience within global or regional solution consulting teams
  • MBA or advanced degree in Life Sciences, Pharmacy, or Business

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Job ID: 147128905

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